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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Drug: ARV-766 Part A&B; Drug: ARV-766 + Abiraterone Part C&D

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Clinical Trial Site
    • Fresno, California, United States, 93720
      • Clinical Trial Site
    • La Jolla, California, United States, 92037
      • Clinical Trial Site
    • Orange, California, United States, 92868
      • Clinical Trial Site
    • Santa Monica, California, United States, 90404
      • Clinical Trial Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Clinical Trial Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Clinical Trial Site
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Clinical Trial Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Clinical Trial Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Clinical Trial Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Clinical Trial Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Clinical Trial Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Clinical Trial Site
  • New York
    • Buffalo, New York, United States, 14203
      • Clinical Trial Site
    • New York, New York, United States, 10065
      • Clinical Trial Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19144
      • Clinical Trial Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • Clinical Trial Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Clinical Trial Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Trial Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trial Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Clinical Trial Site
    • Fairfax, Virginia, United States, 22031
      • Clinical Trial Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Part A,B,C and D:

• Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
• 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).
• Progressive mCRPC

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.
• Progressive mCRPC

Part C & D:

• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease

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.

Part C and D

• Prior treatment with a second generation NHA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARV-766; Oral tablets, once daily in 28 day cycles	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.
Experimental: ARV-766 + Abiraterone; Oral tablets, 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; Other Names: Corticosteroid and ADT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Incidence of Dose Limiting Toxicities of ARV-766	First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug	28 Days
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766	Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.	28 Days
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766	Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.	28 Days
Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC	Evaluate PSA in patients with mCRPC in both dose groups	12 Weeks
Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination	First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug	28 Days
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination	Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.	28 Days
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination	Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.	28 Days
Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC	Evaluate PSA in patients with NHA-naïve mPC	12 Weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Metastatic Prostate Cancer; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Castrate-Resistant; mCRPC adenocarcinoma of prostate; Castrate-Sensitive; mCSPC adenocarcinoma of prostate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Prostatic Neoplasms; Urogenital Neoplasms; Genital Neoplasms, Male; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: CJSB462A12101; ARV-766-mCRPC-101 (Other Identifier: Arvinas Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No