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

Prostate Cancer Metastatic Clinical Trial

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 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067140
• Other study ID #: ARV-766-mCRPC-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2, 2021
• Est. completion date: June 27, 2026

Study information

• Verified date: April 2024
• Source: Arvinas Inc.
• Contact: Arvinas Androgen Receptor, Inc.
• Phone: 475-345-3374
• Email: clinicaltrialsARV-766[@]arvinas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 27, 2026
• Est. primary completion date: December 6, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Clinical Trial Site	Baltimore	Maryland
United States	Clinical Trial Site	Boston	Massachusetts
United States	Clinical Trial Site	Buffalo	New York
United States	Clinical Trial Site	Charlottesville	Virginia
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Detroit	Michigan
United States	Clinical Trial Site	Duarte	California
United States	Clinical Trial Site	Fairfax	Virginia
United States	Clinical Trial Site	Fresno	California
United States	Clinical Trial Site	La Jolla	California
United States	Clinical Trial Site	Lake Mary	Florida
United States	Clinical Trial Site	Madison	Wisconsin
United States	Clinical Trial Site	Myrtle Beach	South Carolina
United States	Clinical Trial Site	Nashville	Tennessee
United States	Clinical Trial Site	New Haven	Connecticut
United States	Clinical Trial Site	New Orleans	Louisiana
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	Orange	California
United States	Clinical Trial Site	Philadelphia	Pennsylvania
United States	Clinical Trial Site	Pittsburgh	Pennsylvania
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	Santa Monica	California
United States	Clinical Trial Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Arvinas Androgen Receptor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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