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Protocol # 21-699

Status

Recruiting

Description

A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth in men with metastatic castration-resistant prostate cancer who have progressed on prior approved systemic therapies

Condition

  • Prostate Cancer Metastatic

Interventions

  • ARV-766 Part A
  • ARV-766 Part B

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Part A: Incidence of Dose Limiting Toxicities of ARV-766
  • Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
  • Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
  • Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC

Enrollment

150

Study Start Date

September 2, 2021

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Arvinas Androgen Receptor, Inc.

Source

Arvinas Inc.

Official title

A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients With Metastatic Castration-Resistant Prostate Cancer

Clinicaltrials.gov Identifier

NCT05067140

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.