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Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

Trial Status: Active

Phase 1 / 2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).

Inclusion Criteria

  • Inclusion Criteria: Part A: - Patients must be male and at least 18 years of age at the time of signing the informed consent. - Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate. - Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide). - Patients with progressive mCRPC - Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). Part B: - Patients must be male and at least 18 years of age at the time of signing the informed consent. - Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate. - Patients must have received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC. - Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer. - Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). Part B - Phase 2 Expansion Cohort Subgroup 4 - Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting. - No prior chemotherapy Exclusion Criteria: Part A: - Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses) - Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug. - Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study - Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug. Part B: - Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses) - Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug. - Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study - Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Kathryn Hilburn
Phone: 310-633-8400
San Francisco
University of California San Francisco
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Connecticut

New Haven
Yale University
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: IN_REVIEW

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: WITHDRAWN

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Arvinas Inc

  • Primary ID ARV-110-mCRPC-101
  • Secondary IDs NCI-2019-03156
  • Clinicaltrials.gov ID NCT03888612