Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial contains a dose escalation cohort and dose expansion cohort. Within each cohort, there are 3 treatment Arms. In Arm A, participants will receive either an escalating or selected dose of CPI-006 administered intravenously once every 21 days until they reach a maximum tolerated dose (MTD) or until disease progression. In Arm B, participants will receive either an escalating or selected dose of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression. In Arm C, participants will receive either an escalating or selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
Conditions
This trial is treating people with Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Cervical Cancer, Ovarian Cancer, Pancreatic Cancer, Endometrial Cancer, Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Bladder Cancer, Metastatic Castration Resistant Prostate Cancer or Non-hodgkin Lymphoma
Eligibility
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
- Willingness to provide tumor biopsies.
Exclusion
- History of severe hypersensitivity reaction to monoclonal antibodies.
- Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
- History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
- The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Corvus Pharmaceuticals, Inc
Scientific Title
A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent, In Combination With CPI-444, And In Combination With Pembrolizumab In Adult Subjects With Advanced Cancers
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