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

NCT05067140 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-05-05

No results posted yet for this study

Summary

A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

ARV-766 Part A&B

Part A: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part B: Oral tablet(s) once daily in 28 day cycles.

DRUG

ARV-766 + Abiraterone Part C&D

Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part D: Combination administered once daily in 28 day cycles. Parts C\&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2027-05-25
Completion
2027-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067140 on ClinicalTrials.gov