Open Actively Recruiting
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
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.
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
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
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