Clinical Trial to Evaluate ARV-766 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-06-27
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the safety and efficacy of ARV-766 in men with metastatic castration-resistant prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arvinas Androgen Receptor, Inc.

Criteria

Inclusion Criteria:

• Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.

• 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

• 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

Exclusion Criteria:

• 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