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
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
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
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
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
