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Drug Treatment Study for Patients with Advanced Cancers
This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
In order to participate you must meet the following criteria:
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Have documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), prostate cancer, and bladder cancer.
- Have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Have at least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of severe hypersensitivity reaction to monoclonal antibodies.
- Have any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
- Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.
- Have used any investigational medication or device in the 30 days prior to screening. Use of such investigational medication during the study is also prohibited.
- Are currently receiving denosumab and are not able to discontinue use prior to enrollment. Substitution with biphosphonates are acceptable.
This is a partial list of inclusion and exclusion criteria.