A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients with Advanced Pancreatic Cancer (CanPan)
Principal Investigator: Dylan Zylla, MD
Study Sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: This is a symptom management study, and many patients with Pancreatic Ductal Adenocarcinoma (PDAC) experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called “symptom burden”) can negatively affect a patient’s quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. The study is looking to determine whether adding cannabis to patient’s treatment plan can improve their symptom burden.
Inclusion Criteria:
– Are at least 18 years old
– Have been diagnosed with locally advanced or metastatic pancreatic cancer and are planning to start systemic treatment for the first time in the metastatic setting, or have started within the last two weeks
– Are experiencing nausea, vomiting, anorexia (loss of appetite), cachexia (wasting), or pain at least once in the 14 days prior to starting the study
– Are eligible and willing to register in the Minnesota Medical Cannabis Program (MMCP)
Exclusion Criteria:
– Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product
– Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)
– Patients with Alzheimer’s dementia, epilepsy, or history of traumatic brain injury
– Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period
– Patients initiating or receiving immunotherapy or non-standard cytotoxic chemotherapy (including patients enrolled/ enrolling in trials of investigational cancer-directed treatments)
– Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control
– Uncontrolled acute or chronic medical conditions, psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study
– Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance
Study Contact:
Alissa Gavenda, RN OCN
(952) 993-6705
alissa.gavenda@parknicollet.com
AMG193-20220127: A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors.
Principal Investigator: Tim Larson, MD
Study sponsor: Amgen, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: 1/2
Purpose of study: The purpose of the study is to determine the safety, tolerability, and to determine the maximum tolerated dose of the study drug AMG 193, or the maximum dose of combination of AMG 193 + IDE397 in adult patients with metastatic or locally advanced MTAP-null solid tumors. This study is split into Part 1 and Part 2. Part 1 is looking at any MTAP-null solid tumors, and Part 2 is looking at Non-small cell lung cancer MTAP-null tumors. AMG 193 is thought to work with the DNA change in your cancer cells to inhibit growth and to kill the cancer cells.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have evidence of MTAP-null or MTAP deletion as determined by lab testing.
– Advanced or metastatic tumor for which there is no curative treatment
Part 1: Any MTAP-null or MTAP deletion solid tumor that has failed standard therapy.
Part 2: MTAP-null or MTAP deletion Non-small cell lung cancer with progression after 1 to 2 lines of prior therapy. Must have had at least PD1 or PD-L1 inhibitor and platinum based chemo, or targeted therapy and chemo if genetic mutations identified (such as EGFR, ALK, MET, RET, ROS1, KRASg12c, etc).
– Ability to swallow oral study drug pill.
– Must have measurable disease according to RECIST 1.1
– Have an ECOG of 0-1.
– Adequate organ function as determined by local lab testing.
– Minimum life expectancy of 12 weeks.
– Archival tissue block must be available to be reviewed by the study lab. (For Part 1 backfill, patient must undergo fresh biopsy during screening, or archival tissue obtained within 6 months prior to study start.)
– Additional criteria may apply and will be discussed with the physician and research team.
Exclusion Criteria:
– Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastasis, or leptomeningeal disease. Patients with treated brain mets must have been treated at least 4 weeks prior to study start, and meet the following criteria: stable or improving neurological symptoms, stable or decreased doses of corticosteroids for at least 14 days prior.
– History of other malignancy within the last 2 years (with the following exceptions: malignancy treated with curative intent and is low risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna, adequately treated cervical carcinoma in situ, breast ductal carcinoma in situ, urothelial papillary noninvasive carcinoma, or carcinoma in situ without evidence of disease).
– Evidence of current interstitial lung disease, pneumonitis, or prior history of interstitial lung disease, or non-infectious pneumonitis within 12 months prior to study start.
– Active infection requiring systemic treatment within 7 days prior to day 1 of study.
– Covid-19 infection. Minimum of 10 days must have passed after symptom onset.
– History of arterial thrombosis within 3 months prior to first dose.
– Myocardial infarct, Congestive heart failure, unstable angina, or cardiac arrhythmia requiring medication within 6 months prior to first dose.
– GI disease causing inability to take oral medication, malabsorption syndrome, gastric/jejunal tube feeds, or uncontrolled inflammatory GI disease (i.e. Crohns, or ulcerative colitis, etc.)
– History of bowel obstruction, abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to study start.
– History of solid organ transplant
– Short or long QT syndrome.
– Major surgery within 21 days prior to first dose
– Any other anti-tumor therapy within 28 days prior to study day 1,
– Prior treatment with an MAT2A inhibitor or PRMT5 inhibitor.
– Prior radiation to >25% of bone marrow
– Therapeutic or palliative radiation therapy within 1 week of study day 1 (or brain mets within 4 weeks prior to C1D1). Patients must have recovered from radiotherapy related toxicity.
– Live vaccine within 4 weeks prior to study drug administration.
– Prescription medications known to be strong CYP3A4/5 inducers or inhibitors.
– Unresolved toxicities from prior anti-cancer therapies.
– Is currently receiving another investigation study drug or device or less than 21 days since ending other study drug or device treatment.
– Hepatitis B or C infection.
– Breastfeeding female subjects which plan to become pregnant while on study through 6 months post last dose.
– Women of childbearing potential (WOCBP) with positive serum pregnancy test 7 days prior to day 1.
– Male subjects with female partners of childbearing potential that are unwilling to use highly effective methods of contraception while on study through 6 months after the last dose.
– Male subjects unwilling to refrain from donating sperm while on study drug through 6 months after the last dose.
– Any history or evidence of other clinically significant disorder, condition, or disease that in the opinion of the physician would interfere with the subjects ability to perform study procedures.
– Additional criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
BNT 372-02: A Phase II, multi-site, randomized, open-label clinical trial to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapeutic agents as first- and second line treatment in triple-negative breast cancer
Principal Investigator: Jayanthi Vijayakumar, MD
Study Sponsor: BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: This study is looking to test the safety and effectiveness of study drug BNT327 (also called PM8002) in triple-negative breast cancer. The study drug is a bi-specific antibody, which means that the study drug consists of an antibody that specifically binds to two different target proteins. Antibodies are protective proteins produced by your immune system. The two target proteins are programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A). By blocking the function of these proteins, study drug could increase your body’s ability to fight infection and disease, reduce the blood supply in your tumor (and thus reduce tumor growth), and reduce or stop tumor spreading.
Inclusion Criteria:
– Must be at least 18 or older.
– Must provide fresh or archival tumor sample during screening period.
– Must have at least 1 measurable lesion per RECIST 1.1
– ECOG of 0-1
– Minimum life expectancy of more than 3 months.
– Must have adequate organ function per local lab tests.
– Must practice highly effective methods of contraception while on study and for 6 months after the last dose of study drug.
– Women of childbearing potential must not donate eggs until after 6 months after last dose. Men must agree not to donate sperm for the same.
Additional criteria may apply and will be discussed with the treating physician and study team.
Exclusion Criteria:
– Pregnant or breastfeeding or if planning to have children during trial or within 60 days after the last dose.
– Has medical, psychological or social condition that, in the opinion of the investigator would impact the patient’s ability to adhere to protocol and visit requirements.
– History of alcoholic abuse, psychotropic drug abuse, or illicit drug addiction.
– Have received any of the following therapies or drugs prior to initial treatment: prior treatment with PDL1/VEGF bispecific antibody.
– Received systemic anti-cancer therapy within 4-weeks prior to starting study drug, or has received palliative radiotherapy within 7 days prior to starting study.
– Received systemic immunosuppressive therapies within 5 weeks prior to starting study drug. Exceptions are local, intranasal, intra-ocular, intra-articular, or inhaled corticosteroids, short-term use (less than 7 days).
– Received systemic corticosteroids (dosage greater than 10mg/day of prednisone or equivalent) within 3 weeks prior to initiation of trial treatment.
– Live or attenuated vaccine within 4 weeks
– Received IV antibiotics within 3 weeks prior to study start.
– Use of any other investigational product within 4 weeks prior to starting study treatment, or is taking part in another investigational interventional clinical trial.
– Major organ surgery, significant trauma, invasive dental procedures within 28 days prior to study start.
– Received allogenic stem cell transplant or organ transplant.
– Brain mets (with certain exceptions, to be discussed with study team and physician).
– Autoimmune disease requiring systemic treatment.
– Other malignant tumors within 5 years prior to trial treatment.
– Significant heart conditions within 6 months prior to study start.
– Hypertension or diabetic condition prior to initiation of trial treatment.
– Serious non-healing wounds, ulcers, or bone fractures.
– Evidence of major coagulation disorders or other significant risks of hemorrhage such as intracranial or intraspinal hemorrhage, tumor lesions invading large blood vessels with risk of bleeding, thrombosis or embolism within 6 months prior to initiation of treatment, clinically significant hemoptysis or tumor hemorrhage within 1 month prior to initiation of trial treatment, anticoagulant therapy for therapeutic purposes within 14 days prior to study start, received anti-platelet drugs within 10 days prior to study start.
– Uncontrolled pleural, pericardial effusion, or ascites requiring recurrent draining.
– Hypersensitivity to trial treatment or active ingredients
– Has HIV or AIDS
– Know active or history of Hepatitis B or C must have viral load below the limit of quantification.
– Has superior vena cava syndrome or spinal cord compression.
– Have TB or history of TB not successfully treated
Additional criteria may apply and will be discussed with the treating physician and study team.
Study Contact:
Alissa Gavenda, RN, OCN
(952) 993-6705
alissa.gavenda@parknicollet.com
Connect Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene Corporation
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of Study: There are three main purposes of this study: (1) To use the information collected to better understand patterns of diagnosis, treatment and outcomes, including disease progression and survival, in patients with MDS and AML; (2) To use the information to better understand patterns of quality of life in patients newly diagnosed with lower-risk MDS, higher-risk MDS, ICUS [Idiopathic Cytopenia of Undetermined Significance] or AML; and (3) To use the results of this study to provide information to better understand the effects of different treatments on a patient’s disease and quality of life. This study does not involve any treatment. Any current treatment will not be affected by participation in this registry study.
Study Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Purpose of Study: This is an observational (non-interventional) study, meaning there is no drug or treatment being provided as part of the study. As the patient, you will receive standard of care and routine clinical practice, with the purpose of the study being to capture patient characteristics, practice patterns, and different treatment strategies when treating the following types of lymphoma; Relapsed/refractory (R/R), diffuse large B-cell lymphoma (DLBCL), R/R Follicular lymphoma (FL), and primary mediastinal b-cell lymphoma (PMBCL). Additionally, patient-reported health-related quality of life (HRQoL) outcomes will be collected from patients.
Inclusion Criteria:
- Must be ≥18 years of age at the time of consent
- Must have 1 of the following histologically confirmed Non-Hodgkin Lymphoma (NHL) subtypes: Diffuse Large B-cell lymphoma (DLBCL), NOS; or DLBCL High-grade lymphoma, NOS, or DLBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
(Epstien-Barr virus-positive or composite DLBCL are allowed)
Follicular lymphoma (FL)
Primary mediastinal B-cell lymphoma (PMBCL) - Must have been previously treated with at least 1 or more prior systemic therapy (i.e. chemotherapy, immunotherapy, chemoimmunotherapy)
- For first relapsed/refractory (R/R) DLBCL, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have started 3L systemic treatment within 60 days prior to enrolling.
- For second R/R DLBCL cohort, participant must have confirmed second R/R disease or after 2L systemic treatment and must have started 3L treatment within 60 days of enrollment
- For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- For first R/R PMBCL cohort, participant must have confirmed first R/R disease during or after 1L systemic treatment and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- Participant must be willing and able to complete enrollment and follow-up health-related quality of life (HRQoL) and social support instruments
- Participants volunteering for the Tissue Sub-Study must consent for use of their blood/tumor biopsies, which were collected as per standard of care, for exploratory analyses.
- These criteria can further be discussed with the physician or study team.
Exclusion Criteria:
- Participant whose prior start and end date of DLBCL, FL, or PMBCL treatment, and prior treatment received, including chemotherapy, radiation, surgery (not including excisional biopsies), and other anticancer therapy, are unknown
- Participant who has any other active malignancy (non-DLBCL, non-PMBCL, or non-FL) for which the participant is receiving treatment at the time of enrollment or any other former malignancy that was diagnosed within 6 months prior to Registry enrollment (with the exception of non-melanoma skin cancer)
- Currently enrolled in any interventional clinical trial where the participant is being treated with an investigational product that cannot be identified.
Study Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
DB1311-O-1001: A Study of DB-1311 in Advanced/Metastatic Solid Tumors
Principal Investigator: Tim Larson, MD
Study sponsor: Dualitybio Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This is a first-in-human study that is looking to test the safety and effectiveness of study drug DB-1311 in solid tumors. The study drug is an antibody-drug combination composed of an anti-B7-H3 antibody and P1021 (a topoisomerase I Inhibitor). It is thought that by interfering with the B7-H3 protein, this may inhibit the growth of cancer cells. P1021 works to promote cancer cell death by interrupting DNA replication. The thought is that combination of these will help target and help the body to destroy the tumor cells.
Inclusion Criteria:
– Must be 18 years or older.
– Confirmed advanced / metastatic solid tumor that progressed / relapsed on standard therapy.
– At least one measurable lesion per RECIST 1.1.
– Has life expectancy of at least 3 months.
– ECOG of 0 – 1.
– LVEF of at least 50%.
– Adequate organ function as determined by lab tests.
– Willing to provide existing tumor tissue samples or undergo fresh tumor biopsy for measurement of biomarkers.
– Male, and female subjects of childbearing potential must agree to highly effect methods of contraception.
– Male subjects must not freeze or donate sperm for at least 4 months after last dose of study drug. Female subjects must not donate, or retrieve ova from time of screening through at least 7 months after last dose of study drug.
Several other cohort specific criteria may apply for Phase 2a of the study depending on disease type.
Part 2a:
SCLC (Cohort 1) –
-Prior treatment with at least 1 platinum therapy for 2 cycles.
NSCLC (Cohort 2) –
-Has received treatment with platinum-based chemo, or anti-PD-1/PD-L1 therapy in advanced/metastatic setting. If patient has genomic mutations other than EGFR mutation, patient must also have been treated with at least 1 genotype-directed therapy.
ESCC (Cohort 3) –
-Received at least 1 prior therapy for unresectable disease.
CRPC (Cohort 4) –
-Progressive metastatic CRPC as defined by PCWG3 criteria.
-Has received prior docetaxel.
-Has received prior novel hormone therapy.
Melanoma (Cohort 5) –
-Confirmed Stage 3 or metastatic melanoma
-Must previously have been treated with PD-1 or PD-L1 inhibitor.
-If pt. has BRAF mutant melanoma, must have had prior treatment that included a BRAF gene or MEK inhibitor.
HCC (Cohort 6) –
-Confirmed HCC and has received 1 or 2 prior systemic regimens for metastatic disease.
-Has experienced progression during or after treatment with anti-PD-1/L1 agent given as monotherapy or combination.
Cervical Cancer (Cohort 7) –
-Recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous histology, and has experienced disease progression during or after treatment with standard of care platinum or doublet therapy.
Other Solid Tumors (Cohort 8) –
-Must have progressed after at least 1 prior standard therapy.
Additional criteria may apply and will be discussed with study team and physician.
Exclusion Criteria:
– Prior treatment with B7-H3 targeted therapy.
– Prior treatment with antibody drug conjugate with topoisomerase inhibitor (such as trastuzumab deruxtecan).
– Has medical history of symptomatic congestive heart failure NYHA class II-IV or serious cardiac arrhythmia requiring treatment.
– Medical history of myocardial infarct or unstable angina within 6 months prior to enrollment.
– Average QTcF > 470 based on ECG results.
– Unable or unwilling to discontinue concomitant medications that are known to prolong QT interval.
– Medical history of interstitial lung disease or has current interstitial lung disease.
– History of underlying pulmonary disorder (pulmonary emboli, severe asthma, COPD, restrictive lung disease, or other significant pulmonary disease that requires supplemental oxygen for treatment).
– Autoimmune, connective tissue, inflammatory disorder where there is suspicion of pulmonary involvement at screening.
– Uncontrolled infection requiring antibiotics, antivirals, or antifungals.
– Known HIV infection.
– Active hepatitis infection. Patients with history of, may be eligible after completing curative treatment, and have viral load below quantification limit.
– Lactating mother, or pregnant within 7 days prior to enrolling into the study.
– Spinal cord compressions or active nervous system metastases that requires corticosteroids. Patients with asymptomatic, radiologically and neurologically stable disease for at least 4 weeks are eligible.
– Has unresolved toxicity from previous anticancer therapy. May be eligible after discussion between treating physician and sponsor.
– Has multiple primary malignancies within 3 years.
– Has substance abuse issues or other medical conditions that, in physician opinion, would interfere with patient’s ability to participate in the study.
Additional exclusion criteria may apply and will be discussed with study team and physician.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HARMONi-3 Study: A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the first-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Principal Investigator: Kurt Demel, MD
Study sponsor: Summit Therapeutics Sub, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This is a randomized study – meaning you have a random chance to be assigned to either the study drug arm, which is Ivonescimab (study drug) + chemotherapy, OR to the standard arm, which is Pembrolizumab (Keytruda) + chemotherapy. The main purpose of the study is to look at overall survival of patients that are taking the study drug plus chemo, vs. the patients taking pembrolizumab plus chemo. The study drug works by attacking or interfering with 2 different parts of cancer growth at the same time. It interferes with the development of new blood vessels to the tumor, and also stimulates the body’s immune system to better identify cancer cells and destroy them.
Inclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Exclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HC366-RC2311: A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma
Principal Investigator: Brian Rank, MD
Study Sponsor: HiberCell Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This study is looking to test the safety and effectiveness, and to find the highest tolerated dose of study drug HC-7366 as single drug or in combination with Belzutifan (Welireg) in patients with Renal Cell Carcinoma. The study has two parts – a dose escalation phase (Finding the highest tolerated dose), and a dose expansion phase (further testing at the highest dose). The study drug works by interfering with cancer cells’ ability to feed themselves and potentially prevent their growth.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have confirmed diagnosis of metastatic Renal Cell Carcinoma.
– Must have progressive disease after receiving at least 2, and no more than 5 prior therapies for stage 4 disease.
– Must have at least 1 measurable lesion per RECIST 1.1.
– Has no RCC tumor that requires immediate surgery.
– If reasonably accessible with minimal risk and patient willing, at least one biopsy at baseline and another at cycle 2 day 1.
– Must have ECOG of 0-1.
– Has adequate organ function as determined by lab tests.
– Must not experience more than 10% weight loss in the last 4 weeks prior to starting study drug.
– Must have at least a 3-month life expectancy as determined by treating physician.
– If female patient of childbearing potential, must agree to highly contraceptive method or maintain abstinence from intercourse during the trial period and at least 90 days following the last dose of study drug. Also must have negative serum pregnancy test at screening.
– Male patients must abstain from intercourse or agree to using highly contraceptive methods during trial period and at least 90 days after the last dose of study drug.
– Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Patient is excluded if they have had prior treatment with Belzutifan or other HIF-2α inhibitor.
– Has received any type of small molecule kinase inhibitor within 2 weeks prior to study.
– Is currently receiving an investigational drug or device within 4 weeks prior to starting study.
– Has received radiotherapy within 2 weeks prior to study. Patient must have recovered from radiotherapy related toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation to non-Central Nervous System disease.
– Is immunodeficient or receiving systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Has any of the following: Pulse oximeter reading of <92%, requires intermittent supplemental or chronic supplemental oxygen.
– Has history of lung disease or pneumonitis within 12 months prior to screening.
– Has clinically significant cardiovascular disease within 6 months from first study drug administration (specifics to be discussed with physician/study team).
– Has additional known malignancy that is progressing or has required active treatment within the last 5 years. Basal cell or squamous cell carcinoma are excluded. Other malignancies are also eligible if they were cured by surgery alone, surgery plus radiotherapy and have been disease free for at least 5 years.
– Has history of, or active central nervous system metastasis. May be able to participate if CNS is radiologically stable for at least 4 weeks and no evidence of enlargement.
– Has moderate to severe Child-Pugh B or C.
– Has known hypersensitivity to active ingredients of study drug or Belzutifan.
– Has history or retinitis or photosensitive skin disorders.
– Has history of severe autoimmune disease or history of organ transplant.
– Is unable to swallow oral medications or has evidence of GI disorder that may impact drug absorption.
– Has known active HIV or Hepatitis B or C.
– Is currently receiving strong or moderate Inducers or Inhibitors of Cytochrome P450 (CYP3A4) that cannot be discontinued during the study.
– Has a history of, or any other active condition that, in the opinion of the investigator, would interfere with the individual’s ability to cooperate with the study requirements.
– Other exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@parknicollet.com
HLX10-005-SCLC301-E: A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Principal Investigator: Yan Ji, MD
Study Sponsor: Shanghai Henlius Biotech
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: This is a Phase 3 study that is looking to study the effects of the study drug HLX10 combined with chemotherapy on extensive-stage small-cell lung cancer. Patients are randomly assigned to either the experimental arm – the study drug + chemotherapy, or the control arm – Atezolizumab (Tecentriq) + chemotherapy. The study drug works by targeting PD-1, and helps restore the body’s function to recognize and combat cancer cells.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must be diagnosed with extensive-stage small-cell lung cancer.
– Must not have had any previous therapy for ES-SCLC
– Patients that received chemoradiotherapy for limited stage SCLC must be treated with curative intent and must have treatment-free period of at least 6 months from the last course of chemo, radiotherapy, or chemoradiotherapy until diagnosis of extensive stage SCLC.
– Must have at least 1 measurable lesion per RECIST 1.1.
– ECOG of 0 – 1.
– Expected survival of at least 12 weeks.
– Normal organ function as determined by screening lab tests.
– Female patients may meet any of the following: Menopause (menses for at least 1 year), or surgically sterilized, or, if of childbearing potential, must have negative serum pregnancy test within 7 days prior to being randomized to the study, and must agree to using highly contraceptive methods while on study treatment. Additionally, must not be breastfeeding.
– Male patients must agree to abstinence or take contraceptive measures through 6 months post last dose of study treatment.
– Additional criteria may apply, and will be discussed with the physician and study team.
Exclusion Criteria:
– Confirmed mixed small-cell lung cancer.
– Other active malignancies within 5 years or at the same time.
– Patients who are preparing for, or have received an organ or bone marrow transplant.
– Pleural or pericardial effusion requiring intervention, or ascites.
– Patients with known Central Nervous System metastases and/or meningitis at screening. The following will be allowed: subjects with asymptomatic brain metastases – will be required to have regular brain imaging done. Subjects with treated brain mets that have been stable for at least 2 months and with discontinued steroids 3 days prior to study start.
– Patients with spinal cord compression that has not been treated with surgery or radiotherapy.
– Patients with myocardial infarct within half a year prior to first dose, or with poorly controlled arrhythmias.
– Class 3 or 4 cardiac insufficiency or LVEF <50%.
– Uncontrolled or symptomatic hypercalcemia.
– Grade 2+ peripheral neuropathy
– HIV infection or positive test for HIV antibody.
– Active pulmonary tuberculosis.
– Previous and current pneumonia, pneumoconiosis, radiation pneumonitis or impaired pulmonary function that, in the opinion of the physician, may interfere with detection and management of study drug-related pulmonary side effects.
– Hepatitis B or C infection.
– Known active or suspected autoimmune diseases. Patients that are stable and that do not need immunosuppressant therapy are allowed to enroll.
– Treatment with live vaccines, COVID-19 vaccine, within 28-days prior to study drug administration. Inactivated viral vaccines for seasonal flu are allowed.
– Patients that are requiring treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to first dose. (Subjects are allowed to use topical or inhaled steroids, and adrenal hormone replacement therapy at less than or equal to 10mg/day of prednisone or similar).
– Active infection requiring systemic therapy within 14 days prior to study drug administration. Patients with history of Covid-19 infection must have negative PCR test prior to first dose of study drug.
– Major surgery within 28 days or radiation within 3 months prior to study start.
– Patient has previously received other immune-checkpoint inhibitors such as PD-1, PD-L1, CTLA4.
– Is currently participating in another ongoing clinical trial or is less than 14 days from the end of a previous clinical trial treatment.
– Has known history of allergy to any monoclonal antibody, or known hypersensitivity to carboplatin or etoposide.
– Additional criteria may apply, and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
LCCC 1710: Feasibility of Collecting and Adjusting Patient-Reported Outcomes for Quality Reporting in Chemotherapy.
Principal Investigator: Dylan Zylla, MD
Study sponsor: Lineberger Comprehensive Cancer Center
Location: HealthPartners Frauenshuh Cancer Center
Purpose of study: This is a quality of life/supportive care study, which means this study does not provide any treatment as part of the study procedures. Instead, patients receiving standard anticancer treatment will answer a questionnaire 5-15 days after the treatment day. The purpose of the study is to test the questionnaire that asks about the symptoms that patients experience following their treatment.
Inclusion Criteria:
– Adults 21+
– Currently starting a systemic cancer treatment (Chemo, neoadjuvant chemo, immunotherapy, and/or targeted therapy)
– Is willing to complete a questionnaire 5-15 days after administration of treatment.
– Is able to complete the questionnaire in English, Spanish, or Mandarin Chinese.
Exclusion Criteria:
– Inability to provide informed consent
– Only receiving hormonal treatment without chemotherapy
– Is participating in a clinical trial involving an experimental drug.
Study Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
MK-5684-004: A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next generation Hormonal Agent (NHA)
Principal Investigator: Dylan Zylla, MD
Study sponsor: Merck Sharpe & Dohme LLC
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to test the safety and effectiveness of the study drug MK-5684 combined with hormone replacement therapy (HRT) compared to alternative Abiraterone acetate or Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
– Have histologically or cytologically confirmed adenocarcinoma of prostate without small cell histology.
– Have current evidence of metastatic disease documented either by bone lesions on bone scan, or by soft tissue disease documented by CT or MRI scan.
– Has prostate cancer progression while receiving androgen deprivation therapy.
– Has had disease progress during or after treatment with one next-generation hormonal agent.
– Has ECOG of 0 – 1.
– Has adequate organ function as determined by lab tests.
– Has provided tumor tissue from fresh core or excisional biopsy from soft tissue that was not previously radiated.
– Participants that test positive for Hepatitis B are eligible if they have received antiviral therapy for at least 4 weeks, and have undetectable load prior to randomization. Additionally, participants with Hepatitis C are eligible if viral load is undetectable at screening.
– HIV positive patients must be on well controlled antiretroviral therapy.
– Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Has other Gastrointestinal condition
– Unable to swallow capsules/tablets
– Has poorly controlled diabetes mellitus
– Has active or unstable cardio/Cerebro-vascular disease or thromboembolic events.
– Has significant abnormal sodium or potassium levels, or hypotension at screening.
– History or family history of long QTc Syndrome.
– Has history of seizures within 6 months prior to signing consent, or condition that may predispose to seizures within 12 months prior to signing consent.
– Has previously received Taxane-based chemotherapy or next-generation hormonal agent for metastatic castration-resistant prostate cancer.
– Has not recovered from previous major surgery or has ongoing surgical complications.
– Has received prior treatment with Radium for prostate cancer.
– Has received CYP450-inducing antiepileptic drugs for seizure.
– Has received radiotherapy within 2 weeks prior to first dose of study drug.
– Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study drug.
– Has received prior systemic therapy including other investigational drugs, or investigational devices within 4 weeks prior to first dose of study drug.
– Has received a live or live-attenuated vaccine within 30 days prior to first dose of study drug.
– Has known hypersensitivity to components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide.
– Has known other malignancy that is progressing or has required active treatment within the past 3 years.
– Is receiving chronic systemic steroid therapy (>10mg / day of prednisone or equivalent).
– Has known central nervous system metastases. Patients with previously treated brain Mets may participate if they have been radiologically stable for 4 weeks and have not required steroid treatment for at least 14 days prior to first dose of study drug.
– Has active autoimmune disease that required systemic treatment in the last 2 years.
– Has active infection that requires treatment.
– Has concurrent Hepatitis B and Hepatitis C virus infection.
– Additional criteria may apply and will be discussed with the study team and physician.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
NALO NT019-101: A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer
Principal Investigator: Rachel Lerner, MD
Study sponsor: Nalo Therapeutics
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This is a two-part study looking at the safety, tolerability, and preliminary efficacy of study drug NX-019 in patients with non small cell lung cancer with EGFR mutation.
Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD).
Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the recommended dose for specific cohorts, and to measure the objective response rate.
Inclusion Criteria:
– Be at least 18 years or older at time of consent.
– Confirmed locally advanced or metastatic EGFR-mutant non small cell lung cancer.
– Patients with NSCLC that have a mutation that is sensitive to Osimertinib.
– Measurable disease based on RECIST 1.1.
– expected life expectancy of 3 months.
– adequate organ and bone function as determined by lab tests.
– Must receive baseline MRI.
– Side effects from prior therapies must be at grade 1 or 0 prior to study start.
– ECOG of 0 – 2.
– Negative serum pregnancy within 72hrs prior to first dose.
– Willingness to utilize conventional highly contraceptive methods for both participant and partner.
The following are cohort specific inclusion criteria for Part 2:
Cohort 1:
-NSCLC w/ EGFR exon 19 deletions, or exon 21 L858R mutations who progressed on EGFR TKI therapy.
Cohort 2:
– NSCLC with EGFR ex20ins mutation, who are not suitable for, or are unwilling to receive available targeted therapy for ex20ins mutations.
Cohort 3:
– NSCLC with EGFR mutations for which there is no targeted therapy available (excluding exon 19, exon 21 L858R, and ex20ins).
*Additional criteria may apply and will be discussed with the study physician and study team.
Exclusion Criteria:
– Known C797X EGFR mutation, or 1 or more known secondary drivers of disease.
– Disease requiring immediate treatment with surgery or radiation.
– Is taking 4mg/day or more of dexamethasone (or equivalent) for managing brain metastasis.
– Received anticancer treatment within 2 weeks prior to study start.
– Had major surgery within 3 weeks prior to study start.
– Received radiation within 4 weeks prior to study start.
– Unstable severe cardiac condition within 6 months prior to study start.
– Uncontrolled or unstable diabetes or psychiatric condition.
– Is dependent on contact lenses (cannot wear glasses).
– History or lung disease requiring systemic steroid therapy, or other significant lung disease.
– Other active malignancy within 2 years or has active infection requiring therapy
– Known immunodeficiency virus, Hepatitis B or C.
– Active GI disease such as Crohn’s disease, ulcerative colitis, or other conditions that can impact drug absorption.
– Pregnant or breastfeeding
– currently using a proton pump inhibitor and cannot refrain from use for 7 days prior to study start.
– Is currently on a strong CYP3A inhibitor or inducer, and cannot refrain from use for 7 days prior to study start.
– Any other condition that, in the opinion of the physician, would impact the patient’s ability to take part in the trial.
*Additional exclusion criteria may apply and will be discussed with the physician and the study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
NP303-102; ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating Crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors receiving targeted-cancer therapies with or without standard chemotherapy regimens
Principal Investigator: Dylan Zylla, MD
Study sponsor: Napo Pharmaceuticals
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: This is a Phase 3 randomized, double-blind placebo-controlled trial looking to evaluate safety and efficacy of prophylactic use of Crofelemer for diarrhea in adult patients with solid tumors. Participants are randomized 1:1 ratio to either crofelemer arm (experimental), or placebo arm. This study is not treating the cancer specifically, but instead is looking at managing diarrhea as a side effect from some of the anti-cancer treatments available.
Inclusion Criteria:
– Patients to receive targeted cancer therapy drugs that have diarrhea incidence of 50% (tyosine kynase inhibitors,CDK inhibitors, anti-EGFRs) for treatment of solid tumors.
– Patient able to provide informed consent.
– Men and Women >/= to 18 years of age.
– Pathologically or radiologically confirmed diagnosis of solid tumors scheduled to receive targeted cancer therapy.
– Patient must be eligible to receive targeted cancer therapy with or without cycle chemotherapy.
– Must have an ECOG of 0-2.
– Must have negative urine pregnancy test at time of consent for women of child-bearing potential.
Exclusion Criteria:
– Receiving any type of immunotherapy
– Any cancer therapy where antidiarrheal medications are mandatory
– Ongoing irritable bowel syndrome or colitis
– Ongoing diarrhea or diarrheal episodes within 7 days prior to randomization to study arm.
– Laxative use within 7 days prior to randomization, or history of constipation that required use of laxatives for more than at least 30 days.
– Inadequate organ function based on lab results
– Use of other investigational drugs within 4 weeks of signed informed consent.
– Use of antibiotics within past 7 days prior to randomization.
– Total colectomy and/or any type of gastrointestinal ostomy
– Major abdominal or pelvic surgery within 3 months, or any previous (within 1 month) or planned abdominal or pelvic radiation
– Active systemic infection requiring ongoing intervention, including oral and IV antibiotics, anti-fungal, anti-parasitic, and anti-viral drugs.
– Inability to comply with study requirements
– Pregnant and/or breastfeeding.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
Nimbus 1150-101: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors
Principal Investigator: Kurt Demel, MD
Study Sponsor: Nimbus Saturn Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I
Purpose of study: The purpose of the study is to look at how effective the study drug NDI-101150 is at treating certain cancer types when it is given as a single drug, or in combination with pembrolizumab (keytruda). The drug works by blocking a protein called HPK1, and this can potentially help the immune system to better recognize and destroy cancer cells. The study is made up of a dose escalation phase, where any solid tumors are accepted, and a dose expansion phase, where only select tumor types are eligible.
Inclusion Criteria:
– Must be 18 years or older at time of signing consent.
– Must have measurable disease via RECIST 1.1.
– Must have recovered from prior therapy (be at Grade 1 or baseline).
– ECOG of 0 – 1.
– Adequate organ function as determined by screening lab tests.
– Female patients that are women of child-bearing potential (WOCBP) must agree to using highly effective contraceptive methods while on study and must have negative serum or urine pregnancy test within 48hrs prior to Cycle 1 Day 1 of study treatment.
– Must be able to swallow study medication.
– Be willing to avoid sun exposure, wear protective clothing, and/or apply sunscreen if sun exposure is unavoidable.
– For Dose Escalation portion of the study: must have advanced or metastatic solid tumors for which no standard therapies are available or must be refractory to standard therapy.
The Following inclusion criteria are for the dose expansion phase, and are in addition to the criteria listed above:
– Must be willing to consent to required tissue biopsy.
– Must have advanced or metastatic Gastric/Gastroesophageal junction, Non-small cell lung cancer, or Renal Cell Carcinoma for which there is no standard therapy available.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Had a previous solid organ or hematopoietic stem cell transplant.
– Central Nervous System disease that is previously untreated or requires steroids or other intervention.
– Prior anti-cancer treatment that includes the following: Systemic anticancer treatment – chemotherapy, antibody or other anticancer therapy less than 4 weeks prior to first dose of study treatment. Radiation therapy, stereotactic body radiation, chemoembolization, small molecule therapy or targeted therapies.
– Significant cardiovascular disease: myocardial infarct/stroke, or unstable angina within 3 months prior to study treatment, Congestive Heart Failure, uncontrolled hypertension, or history of significant ventricular arrhythmias.
– History of severe immune-related adverse events that led to stopping of prior immunotherapy.
– History of severe hypersensitivity reaction to treatment with monoclonal antibodies.
– If patient requires corticosteroids >10mg/day prednisone or equivalent within 14 days prior to day 1. (Some exceptions may apply
– History of lung disease, pneumonitis, or pneumonia on chest scan within the last 6 months.
– Major surgery within 4 weeks prior to starting study drug, or if patient has not recovered from effects of the prior surgery.
– Uncontrolled active infection that requires IV antibiotics, antiviral, or antifungal medication within 14 days prior to study treatment.
– Known additional active malignancy that is requiring treatment (excluding basal cell, or squamous cell skin cancer, or other cancer for which patient has been disease free for more than 2 years).
– Active HIV infection, or Hepatitis B or C infection.
– Known current alcohol or drug abuse.
– unstable or uncontrolled condition, psychiatric illness, or abnormal lab finding that, in the opinion of the physician, would increase the risk to the patient.
– Prior treatment with an HPK1 inhibitor.
– Taking any contraindicated medications that cannot be discontinued prior to starting study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Piqray CGM IIT: Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib (CBYL719A0US16T)
Principal Investigator: Dylan Zylla, MD, Richard Bergenstal, MD
Study sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: The purpose of the study is to characterize and understand the impact of alpelisib on glucose control in patients with breast cancer using Continuous Glucose Monitoring (CGM) and following a hyperglycemia prevention and management regimen.
Inclusion Criteria:
– Adults age 18+ with diagnosis of metastatic Breast cancer that are initiating treatment with Alpelisib.
– Must be willing to and comply with study visits and procedures.
– Must meet standard clinical criteria for utilizing Alpelisib, including Hormone-receptor positive/HER2 negative cancer with presence of PIK3CA mutation.
– Treating oncologist must plan to use Alpelisib until disease progression or unacceptable toxicity.
– Patient must receive cancer care with a HealthPartners Oncologist during Alpelisib treatment phase and must be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
– Must have compatible smartphone, access to compatible smartphone, or ability to digitally upload information from Continuous Glucose Monitor (CGM), or to bring the reader in to the medical visit at least once a month for uploading data.
– Must have life expectancy of at least 3 months.
Exclusion Criteria:
– Has known history or allergy to skin-adhesive material, or previous cutaneous reaction to a continuous glucose monitor.
– Known currently uncontrolled diabetes, defined as most recent HbA1c over 10%, or history of DKA within 6 months prior to enrollment.
– Concurrent use of high-dose vitamin C, defined as more than 1g of oral vitamin C daily, or IV vitamin C infusions.
– Any concurrent severe, or uncontrolled condition that, in the opinion of the investigator, would cause safety risk, compromise protocol compliance, or contraindicate patient’s participation in the study.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
REFRaME-L1: A Phase 2, Open-label Study Evaluating STRO 002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects with Previously Treated Advanced or Metastatic Non small Cell Lung Cancer Expressing FOLR1
Principal Investigator: Kurt Demel, DM
Study Sponsor: Sutro Biopharma, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: The purpose of the study is to assess the safety and determine the good and bad effects of an investigational drug, luveltamab tazevibulin (also called “luvelta”).The study drug belongs to a class of drugs known as antibody drug conjugates (ADC). An antibody is a protein that is produced by the immune system to identify and get rid of foreign objects like bacteria. ADCs are composed of an antibody attached to an anticancer drug. The antibody portion of an ADC is designed to target cancer cells by binding to specific proteins on the cancer cell surface. The study drug is an ADC that binds to a protein known as folate receptor alpha (FOLR1). FOLR1 is a surface protein that is overexpressed (making too many copies of this protein) on certain cancer cells. Once attached to the cell, the ADC is taken inside the tumor cell and the anticancer drug is released inside to kill the cancer cell. This is an investigational drug, meaning you can only get it as part of the clinical trial.
Inclusion Criteria:
– Must be at least 18 years or older at time of consent.
-Confirmed non-squamous/adenocarcinoma or adenosquamous non small-cell lung cancer that is either unresectable stage IIIb/c not amenable for chemoradiation, or stage IV disease.
– Received at least 2 and no more than 4 prior lines of systemic treatment for advanced NSCLC including at minimum: a)subjects without actionable gene mutation must have received platinum-based chemo and an immune checkpoint inhibitor (either separate or combination). b) subjects with actionable gene mutation must have received approved anti-cancer therapy targeting the specific gene, platinum-based chemo, and an immune checkpoint inhibitor if indicated.
– Progressive disease at most recent scan.
– Tumor tissue with FLOR1 expression of at least 25% as determined by central lab testing.
– ECOG of 0-1
– Life expectancy of at least 3 months.
– At least 1 measurable lesion per RECIST 1.1
– Adequate organ function as determined by local lab tests.
– QTc <470 at screening
-Must have negative serum pregnancy test within 7 days if of childbearing potential, and must also utilize highly effective forms of contraception while on study and for at least 6 months after the last dose.
Additional criteria may apply and will be discussed with the treating physician and study team.
Exclusion Criteria:
– Prior treatment with FOLR1-targeting ADCs.
– Prior anticancer therapy within 3 weeks, or radiation or major surgery within 2 weeks prior to first dose of study drug.
– Untreated central nervous system metastasis.
– History of, or Grade 3 pneumonitis/ interstitial lung disease within past 6 months, or during screening.
– History of anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion proteins.
– Sensory or motor neuropathy of >Grade 1.
– Grade 2 or greater toxicity from prior anticancer therapy (with exception of grade 2 adrenal insufficiency or hypothyroidism due to PD-1/L-1 therapy or grade 2 alopecia).
– fatal concurrent or recent malignancy
– Ongoing immunosuppressive therapy with the exception for treated brain metastasis, including corticosteroids. Physiological replacement and use of topical or inhaled corticosteroids is allowed. Dexamethasone can be used as prophylaxis or to treat chemo-induced nausea.
Additional criteria may apply and will be discussed with the treating physician and study team
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
SUNRAY-01: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
Principal Investigator: Kurt Demel, MD
Study sponsor: Eli Lilly and Co.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. The study drug works by attaching itself and keeping the mutated gene in an inactive form so that it stops the tumor cells that have this mutation from continuing to grow. The study has 2 parts; Part A – patients are randomly selected to either Study drug in combination with Pembrolizumab (Keytruda), or to Placebo in combination with Pembrolizumab. Part B – patients are randomly selected to either study drug + pembrolizumab + chemotherapy, OR to placebo + pembrolizumab + chemotherapy. Regardless of which combination, patients still receive at least standard therapy.
Inclusion Criteria
– Must be at least 18 years or older.
– Must have confirmed non-small cell lung cancer with stage IIIB-IIIC or stage IV disease.
– Must have confirmed KRAS G12C mutation.
– Must have a known PD-L1 expression as determined by lab tests.
– Must have measurable disease based on RECIST 1.1
– ECOG of 0 – 1
– Have life expectancy of at least 12 weeks
– Must be able to swallow capsules.
– Women of childbearing potential must have negative serum pregnancy test within 24hrs prior to first dose and must not breastfeed during treatment and for at least 180 days after the last dose is given.
Additional criteria may apply and will be discussed with physician and research team.
Exclusion Criteria
– Patient has additional targetable mutation or alteration in genes such as EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK1/2/3.
– Has known brain metastasis or carcinomatous meningitis. Participants with brain mets may participate in study if any treatment for CNS was completed at least 14 days prior to study start. Patient must also be radiologically, neurologically, and clinically stable for at least 14 days prior to being randomized. Patient also allowed to participate if brain mets are asymptomatic.
– Patient has significant cardiovascular disease or history of myocardial infarct or unstable angina for 6 months prior to study start.
– Has prolonged QT interval as determined by ECG.
– Has uncontrolled, disease-related, pericardial or pleural effusion.
– History of pneumonitis or interstitial lung disease that required treatment with steroids, or has current pneumonitis/interstitial lung disease.
– Has autoimmune disease that has required treatment in the last 2 years. (Replacement therapy such as thyroxine, insulin or physiologic corticosteroids for adrenal or pituitary insufficiency are allowed.)
– History or solid organ transplant or allogenic stem cell transplant.
– Has active fungal or bacterial infection, HIV, or viral hepatitis (A, B, or C). HIV patients must be on ART and have well-controlled disease as defined by specific criteria at screening.
– Patient has pre-existing medical condition that, in the opinion of the treating physician, would interfere with the patient’s ability to be on the trial.
– Have significant active malabsorption syndrome or other condition that would affect the patient’s ability to absorb the study drug.
– Other known malignancy that is progressing and has required active treatment within the past 2 years.
Additional criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
The Connect for Cancer Prevention Study
Principal Investigator: Jeanette Ziegenfuss, PhD
Study sponsor: The National Cancer Institute (NCI), part of the National Institutes of Health (NIH)
Location: HealthPartners Neuroscience Center, Park Nicollet Clinic Chanhassen, Park Nicollet 3850 Building, HealthPartners Riverway Clinic Elk River
Purpose of study: The Connect for Cancer Prevention Study will help us better understand the causes of cancer and how to prevent it. HealthPartners is one of nine health care systems throughout the country to partner with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for Connect. The study will include 200,000 adults.
Participants will be asked to answer online health surveys, donate samples of blood, urine, and saliva, and share access to their electronic health records. This information will help researchers study the health and behavior patterns that may affect cancer risk. It takes time to understand the causes of cancer, so Connect will go on for many years. The longer you participate, the more we may learn.
Inclusion Criteria: HealthPartners patients between 30 and 70 years old who have never had cancer. People who have or once had non-melanoma skin cancer, or a condition that raises the risk of getting cancer (such as DCIS, or stage 0 breast cancer), can still join.
Study Contact:
The Connect team at HealthPartners
(952) 967-5067
ConnectStudy@HealthPartners.com
XTX301-01/02-001: A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Principal Investigator: Jayanthi Vijayakumar, MD
Study sponsor: Xilio Development Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The main purpose of this study is to determine if XTX301 is safe and well-tolerated in participants with advanced solid tumors. This is the first time XTX301 is going to be given to humans, so this study will also serve to determine the recommended XTX301 dose and schedule in later clinical studies.
Inclusion Criteria:
– Patient must be at least 18 years or older at time of consent.
– Must meet the following disease criteria:
a. Part 1A – any confirmed solid tumor that is locally advanced or metastatic that has failed standard treatments, or for which there is no standard therapy available.
b. Part 1B – Locally advanced or metastatic tumor that is any of the following: Melanoma, non-small cell lung cancer (NSCLC), Head and Neck Squamous cell, Triple-negative breast (TNBC), Cervical cancer, MSI-H/dMMR colorectal, or MSI-H/dMMR endometrial cancer.
– Patient must not have received prior anticancer therapy for at least 28 days prior to starting study treatment, and must have returned to baseline or grade 1 for any side effects from previous therapy.
– Must have ECOG of 0-2.
– Patient must have adequate organ function as determined by local lab tests.
– For Part 1B only: patients must be willing to undergo a tumor biopsy before starting, and while on study treatment.
– Women of Childbearing Potential (WOCBP) must be willing to abstain from sexual activity, or use highly effective contraception. Additionally, must also have a negative serum pregnancy test at the time of study enrollment and before each dose of study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Must not have had previous treatment with IL-12 therapy
– Patients with known liver metastasis are excluded, unless previous discussion between treating physician and study medical monitor approves the patient to enroll.
– Concurrent anticancer therapy, immune therapy, or cytokine therapy, or other antineoplastic therapy during the study.
– History of significant pulmonary disease, interstitial lung disease or pulmonary fibrosis.
– History of significant heart disease, uncontrolled hypertension, congestive heart failure, or myocarditis.
– Possible area of non-disease related necrosis, such as an active ulcer, a non-healing wound, or intercurrent bone disease.
– Has active central nervus metastases, or carcinomatous meningitis.
– Active autoimmune disease that required therapy in the past 2 years, including use of corticosteroids, or immunosuppressive drugs.
– Has an active infection that requires systemic therapy within 4 weeks prior to receiving study drug.
– Has a history of Grade 3 or higher immune-related toxicities from prior immunotherapy unless it resolved within 14 days.
– Has had history of severe hypersensitivity to monoclonal antibodies
– Is pregnant or breastfeeding.
– Has active hepatitis B or C infection.
– Has had prior gene therapy treatment, organ transplant, or hematopoietic stem-cell transplant.
– Is currently using or has received another investigational drug or device within 4 weeks prior to starting study drug.
– Has received a live or live-attenuated vaccine within 4 weeks prior to first dose.
– Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
