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
2 other identifiers
interventional
152
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2021
Longer than P75 for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2021
CompletedFirst Submitted
Initial submission to the registry
September 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2027
May 5, 2026
April 1, 2026
5.7 years
September 23, 2021
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Study Arms (2)
ARV-766
EXPERIMENTALOral tablets, once daily in 28 day cycles
ARV-766 + Abiraterone
EXPERIMENTALOral tablets, once daily in 28 day cycles
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Part C and D
- Prior treatment with a second generation NHA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Clinical Trial Site
Duarte, California, 91010, United States
Clinical Trial Site
Fresno, California, 93720, United States
Clinical Trial Site
La Jolla, California, 92037, United States
Clinical Trial Site
Orange, California, 92868, United States
Clinical Trial Site
Santa Monica, California, 90404, United States
Clinical Trial Site
New Haven, Connecticut, 06510, United States
Clinical Trial Site
Washington D.C., District of Columbia, 20007, United States
Clinical Trial Site
Lake Mary, Florida, 32746, United States
Clinical Trial Site
Chicago, Illinois, 60611, United States
Clinical Trial Site
New Orleans, Louisiana, 70112, United States
Clinical Trial Site
Baltimore, Maryland, 21204, United States
Clinical Trial Site
Boston, Massachusetts, 02114, United States
Clinical Trial Site
Detroit, Michigan, 48201, United States
Clinical Trial Site
Buffalo, New York, 14203, United States
Clinical Trial Site
New York, New York, 10065, United States
Clinical Trial Site
Philadelphia, Pennsylvania, 19144, United States
Clinical Trial Site
Pittsburgh, Pennsylvania, 15232, United States
Clinical Trial Site
Myrtle Beach, South Carolina, 29572, United States
Clinical Trial Site
Nashville, Tennessee, 37203, United States
Clinical Trial Site
San Antonio, Texas, 78229, United States
Clinical Trial Site
Charlottesville, Virginia, 22908, United States
Clinical Trial Site
Fairfax, Virginia, 22031, United States
Clinical Trial Site
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2021
First Posted
October 5, 2021
Study Start
September 2, 2021
Primary Completion (Estimated)
May 25, 2027
Study Completion (Estimated)
May 25, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share