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

Clinical Trial Details

This clinical trial is for adult men who have metastatic prostate cancer. This trial has multiple arms, or portions. Participants will only take part in one portion of the study.
   
The purpose of the first portion of this study is to assess the safety and tolerability (good and bad effects) and how prostate cancer responds to two different doses of the investigational study drug ARV-766 in men with metastatic prostate cancer who have progressed on prior approved systemic therapies for disease like theirs.
   
In the second portion of the study, the safety and tolerability of ARV-766 will be assessed in combination with another drug called abiraterone in men with metastatic prostate cancer who have not received prior novel hormonal therapies.
   
ARV-766 is investigational, which means it has not yet been approved by the U.S. Food and Drug Administration (FDA). Abiraterone is an approved systemic therapy for metastatic prostate cancer.
   
Each study treatment cycle lasts 28 days. In the first portion of the study, participants will be taking a certain dose of ARV-766 by mouth once each day with food. Treatment cycles will continue as long as the participant's disease does not progress and cause them worsening symptoms and they do not have unacceptable side effects.
   
In the second portion of the study, study treatment cycles also last 28 days. Participants will take ARV-766 by mouth once each day with food. Participants will take the abiraterone on an empty stomach with water. Participants will also take a corticosteroid with the abiraterone and ADT. ADT (LHRH agonist/antagonist) stops the body from producing testosterone and is given as regular shots: once a month, once every 3, 4, or 6 months or once per year, depending on what the participant and their study doctor choose. This will continue as long as the participant's disease does not progress and cause them worsening symptoms and they do not have unacceptable side effects to the study treatment. If the participant has been on combination study treatment for 12 months and their cancer is responding with no detectable disease, their study doctor may decide to stop ARV-766 and continue with abiraterone, corticosteroid, and ADT.

Key Eligibility: 
  1. Adult men with histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
  2. For the first portion of the study, participants must have received at least one but no more than 3 prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone); and participants must have received no more than 2 prior chemotherapy regimens. This is not applicable to participants in the second portion of the study.

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025780

ClinicalTrials.gov:

NCT05067140

Sponsor:

ARV-766-mCRPC-101

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease