Prostate Cancer Clinical Trial
A Study of ARV-766 Given by Mouth in Men With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on Prior Approved Systemic Therapies
This study will evaluate the safety and efficacy of ARV-766 in men with metastatic castration-resistant prostate cancer.
Part A and B:
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
• 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).
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.
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.
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There are 21 Locations for this study
Duarte California, 91010, United States
La Jolla California, 92037, United States
Los Angeles California, 90024, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
New Haven Connecticut, 06510, United States
Bradenton Florida, 34211, United States
Saint Petersburg Florida, 33705, United States
Chicago Illinois, 60611, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21204, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Buffalo New York, 14203, United States
Philadelphia Pennsylvania, 19144, United States
Pittsburgh Pennsylvania, 15232, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37203, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Madison Wisconsin, 53705, United States
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