Treatment Study for Patients with Selected Incurable Cancers

Clinical Trial 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. (Study Protocol CPI-444-001)

National Clinical Trial Number:

NCT02655822

Clinical Trial Protocol Description:

This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant (formerly 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 ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells. This study has two sub-studies which are Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Renal Cell Carcinoma (RCC) Substudy.

The purpose of mCRPC substudy is to evaluate if ciforadenant can be given safely to people with prostate cancer together with atezolizumab. Whereas in the RCC substudy, it will investigate if ciforadenant can be given safely to people with kidney cancer together with atezolizumab.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  1. Are at least 18 years of age.
  2. Have an ECOG Performance Status 0-1.
  3. Have a histologically or cytologically documented incurable cancer with a diagnosis for at least one of the following specific disease types: NSCLC, MEL, RCC, TNBC, and mCRPC, colorectal (MSI or MMR- deficient only), and urothelial bladder cancer.
  4. Have at least one measurable lesion per RECIST.
  5. Previously treated brain or meningeal metastases must be without CT/MRI evidence of progression compared to last brain imaging, and the patient must be off immunosuppressive doses of steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks prior to study drug administration.
  6. Have a mandatory fresh tumor tissue biopsy collected at screening for Step 5 subjects. For Steps 3 or 5, archival tumor tissue for the subject.
  7. Have failed at least one curative or standard therapy option.

This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Philip Bonomi, MD

Contact Information

Rush Cancer Center Clinical Trials Office