MC# 18-08 - A Phase I/Ib 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

  • Agent(s): CPI-006, CPI-444, Pembrolizumab
  • Disease Type(s): Bladder, Breast, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatocellular, Lung-NSCLC, Lung-SCLC, Lymphoma, Melanoma, Mesothelioma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Solid Tumor, Squamous Cell, Thyroid, Glioblastoma, Cholangiocarcinoma, Breast- Triple Negative
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Immunotherapy, Monoclonal Antibody, Small Molecule
  • Molecular Target(s): A2A, PD-1, PD-L1 (CD274), CD73

Mechanism of Action

CPI-006 is a monoclonal antibody directed against CD73, a protein expressed on the surface of tumor cells. CD73 has enzymatic activity that converts adenosine monophosphate (AMP) to adenosine. In the tumor microenvironment adenosine has an immunosuppressive effect mediated by interaction with the adenosine receptors on lymphocytes. The investigational antibody is designed to inhibit the enzymatic activity of CD-73 in order to lower the level of adenosine in the tumor microenvironment.

CPI-444, an investigational small molecule inhibitor of the lymphocyte adenosine receptor

Pembrolizumab, an anti-PD-1 checkpoint antibody

Purpose

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.

Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • Documented incurable cancer with one of the following histologies: non-small 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).
  • At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease.
  • Willingness to provide tumor biopsies.
Exclusion Criteria
  • History of severe hypersensitivity reaction to monoclonal antibodies.
  • Subjects who have received prior therapy with regimens containing cytotoxic T-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.

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT03454451?term=NCT03454451&rank=1

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Re: MC# 18-08