Prostate Cancer Clinical Trial

A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

Summary

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

View Eligibility Criteria

Eligibility 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 is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT05067140

Recruitment Status:

Recruiting

Sponsor:

Arvinas Androgen Receptor, Inc.

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There are 23 Locations for this study

See Locations Near You

Clinical Trial Site
Duarte California, 91010, United States
Clinical Trial Site
Fresno California, 93720, United States
Clinical Trial Site
La Jolla California, 92037, United States
Clinical Trial Site
Orange California, 92868, United States
Clinical Trial Site
Santa Monica California, 90404, United States
Clinical Trial Site
New Haven Connecticut, 06510, United States
Clinical Trial Site
Washington District of Columbia, 20007, United States
Clinical Trial Site
Lake Mary Florida, 32746, United States
Clinical Trial Site
Chicago Illinois, 60611, United States
Clinical Trial Site
New Orleans Louisiana, 70112, United States
Clinical Trial Site
Baltimore Maryland, 21204, United States
Clinical Trial Site
Boston Massachusetts, 02114, United States
Clinical Trial Site
Detroit Michigan, 48201, United States
Clinical Trial Site
Buffalo New York, 14203, United States
Clinical Trial Site
New York New York, 10065, United States
Clinical Trial Site
Philadelphia Pennsylvania, 19144, United States
Clinical Trial Site
Pittsburgh Pennsylvania, 15232, United States
Clinical Trial Site
Myrtle Beach South Carolina, 29572, United States
Clinical Trial Site
Nashville Tennessee, 37203, United States
Clinical Trial Site
San Antonio Texas, 78229, United States
Clinical Trial Site
Charlottesville Virginia, 22908, United States
Clinical Trial Site
Fairfax Virginia, 22031, United States
Clinical Trial Site
Madison Wisconsin, 53705, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT05067140

Recruitment Status:

Recruiting

Sponsor:


Arvinas Androgen Receptor, Inc.

How clear is this clinincal trial information?

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