NCT05067140

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-09-02
• Primary completion: 2027-05-25
• Completion: 2027-05-25
• First posted: 2021-10-05
• Last updated: 2025-03-17

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study