A Phase I/IB Study of Immunotherapy with CPI-444 Alone and with Atezolizumab in Patients with Metastatic Solid Tumors

Full Title

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers

Purpose

CPI-444 and atezolizumab are immunotherapy drugs that boost the power of the immune system for recognizing and killing cancer cells. CPI-444 is an investigational drug that does this by blocking a protein called the adenosine receptor, while atezolizumab blocks a protein called PD-L1. In this study, researchers want to find the best dose of CPI-444 to give alone and in combination with atezolizumab in patients with metastatic solid tumors that have come back or continued growing despite treatment.

Atezolizumab is approved for treating bladder cancer; its use in this study is considered investigational. CPI-444 is taken orally (by mouth), while atezolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic non-small cell lung cancer, melanoma, renal cell cancer, triple-negative breast cancer, head and neck cancer, colorectal cancer, or bladder cancer that cannot be cured using standard therapies.
  • Patients' cancers must have grown or come back despite at least one prior regimen of treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

16-352

Phase

I

Investigator

Co-Investigators

Locations