CPI-006 Alone and in Combination With CPI-444 and With Pembrolizumab for Patients With Advanced Cancers

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. This trial is composed of dose escalation and dose
expansion cohorts.

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 Criteria

1. 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.