1002-CL-0101: A Phase 1 Study of ASP1002 in participants with Metastatic or Locally Advanced Solid Tumors
Principal Investigator: Tim Larson, MD
Study Sponsor: Astellas Pharma Global Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: This is a first-in-human study that is looking to study the safety, and tolerability to determine the maximum tolerated dose of study drug ASP1002. The study is open to multiple tumor types – NSCLC, US, CRC, prostate adenocarcinoma, ovarian, and triple negative breast cancer. It is made up of two parts – Part 1: Dose escalation, where the study will determine the highest dose tolerable, and Part 2: dose expansion, where the determined dose will be tested in the tumor types that had the best response to the study drug.
Inclusion Criteria
– Be 18 years or older at study start.
– Must have locally advanced or metastatic solid tumor as determined by pathology records or biopsy.
For dose escalation, patient must have one of the following tumor types: non small-cell lung cancer, urothelial carcinoma, colorectal cancer, prostate adenocarcinoma, epithelial ovarian cancer, or triple negative breast cancer.
For dose expansion, patient must have: NSCLC, UC, CRC, or any tumor type which had confirmed response observed during the dose escalation part.
– Has progressed on, is intolerant to, refused standard therapy, or there is no standard therapy that would provide clinical benefit. (No limit on prior number of lines of therapy)
– Patient has accessible archival tissue that is less than 6 months old from primary or metastatic site. Patients without available tissue will need to undergo biopsy, or if biopsy deemed unsafe, case may be discussed with the medical monitor. Additionally, will undergo an on-treatment biopsy.
– Must have at least 1 measurable lesion per RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have completed previous radiotherapy at least 2 weeks prior to study start.
– Must have predicted life expectancy of at least 12 weeks per treating physician.
– Must have adequate organ function as determined by local lab tests, and lab values must be collected within 7 days prior to first dose.
– Female participant is not pregnant.
– Participants must agree to not breastfeed starting at screening, throughout the study, and for 90 days post last dose. Additionally, participants must agree to use highly effective forms of contraception and must not donate sperm from screening, while on study, and for 90 days post last dose.
– Must not participate in another interventional study while receiving ASP1002.
Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Weighs less than 40kg.
– Has grade 2 or higher toxicity per CTCAE that is due to prior therapies.
– Symptomatic central nervous system metastasis or uncontrolled CNS disease. (Patient with previously treated CNS mets may be eligible if they are clinically and radiologically stable for at least 4 weeks prior to study start, and are not currently on systemic steroids of 10mg prednisone or more per day)
– Patient has active autoimmune disease. Patients with type 1 diabetes, endocrinopathies, stable replacement therapy, or skin disorders such as alopecia, vitiligo, or psoriasis are allowed.
– Has myocardial infarct, or unstable angina within 6 months, or has symptomatic congestive heart failure or other clinically significant cardiac condition.
– Has QTcF of more than 470ms within 7 days of study start.
– LVEF< 45% per screening echocardiogram.
– Has known HIV infection. Patient is allowed if CD4+ T cell counts are equal to or greater than 350 cells/μL and patient has no history of AIDS defining opportunistic infections within the last 6 months.
– Positive serology testing.
– History of drug-induced pneumonitis, ILD, current pneumonitis, or prior history requiring high-dose glucocorticoids.
– Uncontrolled illness such as active infections, substance abuse or psychiatric illness, or social situations that would impact the patient’s ability to comply with study requirements.
– Prior bone marrow or solid organ transplant.
– Has had major surgery, and has not recovered, within 28 days prior to study start.
– Positive COVID-19 test within 10 days prior to study start.
– Has received any other investigational therapy, antineoplastic therapy, or immunotherapy within last 21 days.
– Requires or has received systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Patient has discontinued prior immunomodulatory therapy due to grade 3 or higher that was immune-related and deemed life-threatening by the treating physician.
– Has other active malignancy requiring therapy.
– Has received prior anti-CD137 therapy.
– Received a live vaccine within last 28 days prior to study start.
Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@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
INBRX-106: An Open-Label, Multicenter, First-in-Human, Dose Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination with Pembrolizumab in Subjects with Locally Advanced or Metastatic Solid Tumors
Principal Investigator: Dylan Zylla, MD
Study sponsor: Inhibrx, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: 1/2
Purpose of study: This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab (Keytruda).
Inclusion Criteria:
– Non small cell lung cancer with confirmed, locally advanced metastatic disease that has progressed in no more than 2 lines of standard therapy, and must include at least one PD-1/L1 regimen.
– CPI naïve patients with:
Histologically confirmed head and neck small cell cancer (non-pharyngeal)
Histologically confirmed nasopharyngeal carcinoma.
– Known PDL1 IHC status. Existing test results are acceptable. Specific TPS % requirements are cohort dependent. If TPS is not available, a biopsy or archival tissue is required to be shipped to study lab to determine TPS score.
– Measurable disease based on RECIST 1.1
– Adequate organ function as determined by local lab tests.
– ECOG of 0 – 1.
– Estimated life expectancy, in opinion of treating physician, of at least 12 weeks.
– Female subjects of childbearing potential and male subjects must be willing to abstain or agree to use highly effective forms of contraception while on study and through 4 months after the last dose of study drug.
*Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Prior exposure to OX40 agents.
– Receiving any investigational drug or approved anticancer drug within 4 weeks prior to first dose of study drug.
– Receiving radiotherapy within 2 weeks prior to first dose of study drug.
– Allergy or sensitivity to INBRX-106 or known allergies to antibodies produced from Chinese hamster ovary cells, which in the opinion of the treating physician, could suggest increased potential for hypersensitivity to INBRX-106. Additionally, hypersensitivity to pembrolizumab or its excipients, or hypersensitivity to chemotherapy agents, folic acid, or vitamin B12.
– Hematologic malignancies.
– For subjects with NSCLC: Having received >30Gy within 6 months prior to first dose. Subjects with non-squamous NSCLC with EGFR mutations or ALK gene rearrangements are excluded. Additionally, excluded if unable or unwilling to take Folic Acid or vitamin B12 supplement.
– Mixed histology (adeno-squamous) are allowed if predominant type is non-squamous. If small cell elements are present, subject is excluded.
– Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain mets are eligible if they are radiologically stable, without evidence of progression for at least 4 weeks, and without requiring steroid treatment for at least 14 days prior to first dose of study drug.
– Prior or concurrent malignancies (exception: patients with prior or concurrent malignancies whose natural history or treatment do not have potential to interfere with safety or efficacy assessments of INBRX-106 may be allowed after discussion of case with study medical monitor).
– Grade 3 or greater irAEs, or irAEs that led to discontinuation of prior immunotherapy.
– Active autoimmune disease or documented history of autoimmune disease that requires systemic steroids or other immunosuppressive medication. (Exception: endocrinopathies managed with hormone replacement therapy such as hypothyroidism, type 1 diabetes, and glomerulonephritis, are allowed).
– diagnosis of immunodeficiency or treatment with systemic immunosuppressive medication within 7 days prior to first dose of study drug.
– Patients who received granulocyte colony-stimulating factor, granulocyte-macrophage colony stimulating factor, or erythropoietin within 14 days prior to the first dose of the study drug.
– History of Hep B, Hep C, or HIV infection. (Additional criteria may apply and will be discussed in greater detail with study team)
– Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease within 3 months prior to first dose of study drug. LVEF <50%, NYHA class III or IV congestive heart failure, uncontrolled hypertension, or oxygen saturation of <92%.
– Active interstitial lung disease or pneumonitis, history of interstitial lung disease or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
– Active significant pulmonary embolism within 12 weeks prior to first dose of study drug.
– Major surgery within 4 weeks prior to first dose of study drug.
– Active infection requiring systemic therapy within 4 weeks prior to first dose of study drug.
– Pregnant or nursing females.
– Prior organ transplant or allogenic peripheral blood stem cell bone marrow transplantation.
– Live Vaccine within 4 weeks.
– Known documented or suspected history of illicit drug use that would interfere with patient’s ability to adhere to study requirements and attend study visits.
– Any other disease or significant abnormality that, in the opinion of the physician, would interfere with the patient’s ability to participate in the study.
*Additional criteria may apply and will be discussed in detail with the physician and the study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.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
