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Title:
A Phase 1/1b multicenter study to evaluate the humanized anti-CD 73 antibody, CPI-006, as a single agent, or in combination with Ciforadenant with Pembrolizumab, and with Ciforadenant plus pembrolizumab in adult subjects with advanced cancers (CPI-006-001)
Protocol Number:
J18106
Phase:
Phase I
Physician:
Kristen Marrone
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors and Non-Hodgkin lymphoma.Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with CPI-444 and with pembrolizumab. Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with CPI-444 and with pembrolizumab. Identify the MDL(maximum dose level) of single agent CPI-006.
Eligibility:
Inclusion Criteria:1.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.2.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.3.At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).4.At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease.5.Willingness to provide tumor biopsies.Exclusion Criteria1.History of severe hypersensitivity reaction to monoclonal antibodies.2.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.3.History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.4.The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.5.Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Treatment:
Experimental: Cohort 1a Drug: CPI-006 Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression. Experimental: Cohort 1b Drug: CPI-006 + CPI-444 Subjects will receive escalating doses 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. Experimental: Cohort 1c Drug: CPI-006 + pembrolizumab Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression. Experimental: Cohort 2a Drug: CPI-006 Selected dose of CPI-006 administered intravenously once every 21 days until disease progression. Experimental: Cohort 2b Drug: CPI-006 + CPI-444 Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression. Experimental: Cohort 2c Drug: CPI-006 + pembrolizumab Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Population:
Adult
Last Update
02/27/2020 05:03 AM