Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers

NCT02655822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2021-08-30

No results posted yet for this study

Summary

This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, 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.

Conditions

  • Renal Cell Cancer
  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Ciforadenant

100 mg orally twice daily for the first 14 days of each 28-day cycle.

DRUG

Ciforadenant

100 mg orally twice daily for 28 days of each 28-day cycle.

DRUG

Ciforadenant

200 mg orally once daily for the first 14 days of each 28-day cycle.

DRUG

Ciforadenant + atezolizumab

Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.

DRUG

Ciforadenant

Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Corvus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mehrdad Mobasher, MD, MPH · Corvus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-06-30
Completion
2021-07-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655822 on ClinicalTrials.gov