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

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 and B:

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

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).

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.

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT05067140

Recruitment Status:

Recruiting

Sponsor:

Arvinas Androgen Receptor, Inc.

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There are 15 Locations for this study

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Clinical Trial Site
La Jolla California, 92037, United States
Clinical Trial Site
Orange California, 92868, United States
Clinical Trial Site
New Haven Connecticut, 06510, United States
Clinical Trial Site
Chicago Illinois, 60611, United States
Clinical Trial Site
New Orleans Louisiana, 70112, 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
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
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:

150

Study ID:

NCT05067140

Recruitment Status:

Recruiting

Sponsor:


Arvinas Androgen Receptor, Inc.

How clear is this clinincal trial information?

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