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

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer Metastatic
• Interventions: Drug: ARV-766 + Abiraterone Part C&D; Drug: ARV-766 Part A&B

• Registration Number: NCT05067140
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-05-25
• Study Completion: 2027-05-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARV-766 + Abiraterone	ARV-766 + Abiraterone Part C&D	Oral tablets, once daily in 28 day cycles
ARV-766	ARV-766 Part A&B	Oral tablets, once daily in 28 day cycles

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Madison, Wisconsin, United States