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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Corvus Pharmaceuticals, Inc.
Study ID
NCT02655822
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Castration Resistant Prostate Cancer
  • Renal Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ciforadenant — DRUG
    100 mg orally twice daily for the first 14 days of each 28-day cycle.
  • Ciforadenant — DRUG
    100 mg orally twice daily for 28 days of each 28-day cycle.
  • Ciforadenant — DRUG
    200 mg orally once daily for the first 14 days of each 28-day cycle.
  • Ciforadenant + atezolizumab — DRUG
    Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
  • Ciforadenant — DRUG
    Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Jul 2021
Primary completion
Jun 30, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
502 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Closed
    Ciforadenant
  • Experimental: Cohort 2 - Closed
    Ciforadenant
  • Experimental: Cohort 3 - Closed
    Ciforadenant
  • Experimental: Cohort 4
    Ciforadenant + atezolizumab
  • Experimental: Cohort 5 - Closed
    Ciforadenant

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab [ Time Frame: 28 days following first administration of ciforadenant ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85719-
University of California - San FranciscoSan FranciscoCalifornia94143-
Stanford Cancer InstituteStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06510-
University of Miami Hospital and ClinicsMiamiFlorida33136-
Rush University Medical CenterChicagoIllinois60612-
University of Chicago Medical CenterChicagoIllinois60637-
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of MedicineBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland ClinicClevelandOhio44195-
University of Pittsburgh Medical Center Cancer CenterPittsburghPennsylvania15232-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZUniversity of California - San Francisco· San Francisco, CAStanford Cancer Institute· Stanford, CAYale University· New Haven, CTUniversity of Miami Hospital and Clinics· Miami, FLRush University Medical Center· Chicago, IL

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