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A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Trial Status: closed to accrual
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or
in combination with abiraterone in men with metastatic prostate cancer.
Inclusion Criteria
Inclusion Criteria:
Part A,B,C and D:
- Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of
the prostate.
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone
analog or inhibitor, or orchiectomy (surgical or medical castration).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part A:
- Progression on at least 2 prior approved systemic therapies for metastatic prostate
cancer (at least one must be a second-generation androgen inhibitor, e.g.,
abiraterone, enzalutamide, darolutamide, apalutamide).
- Progressive mCRPC
Part B:
- Participants must have received at least one but no more than three prior second
generation anti-androgen agents (e.g., enzalutamide or abiraterone).
- Participants must have received no more than two prior chemotherapy regimens.
- Progressive mCRPC
Part C & D:
• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence
of metastatic disease
Exclusion Criteria:
Part A and B:
- Known symptomatic brain metastases requiring steroids (above physiologic replacement
doses).
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular
disease, or previous gastric resection or lap band surgery.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to
>25% of the bone marrow.
- Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
- Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except
agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas
the exclusion period must be 6 weeks and for abiraterone 4 weeks.
Part C and D
• Prior treatment with a second generation NHA
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05067140.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center