Last Update: Jan 13, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CJSB462A12101
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Prostate Cancer Metastatic
Phase1, Phase2
Recruiting
220
Sep 02, 2021
Jun 27, 2026
Male
18 Years - (Adult, Older Adult)

Interventions

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
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.

Eligibility Criteria

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

Clinical Trial Site

Recruiting

Orange,California,92868,United States

Clinical Trial Site

Recruiting

Myrtle Beach,South Carolina,29572,United States

Clinical Trial Site

Recruiting

Boston,Massachusetts,02114,United States

Clinical Trial Site

Recruiting

Santa Monica,California,90404,United States

Clinical Trial Site

Recruiting

Nashville,Tennessee,37203,United States

Clinical Trial Site

Recruiting

Detroit,Michigan,48201,United States

Clinical Trial Site

Recruiting

New Haven,Connecticut,06510,United States

Clinical Trial Site

Recruiting

San Antonio,Texas,78229,United States

Clinical Trial Site

Recruiting

Buffalo,New York,14203,United States

Clinical Trial Site

Recruiting

Lake Mary,Florida,32746,United States

Clinical Trial Site

Recruiting

Charlottesville,Virginia,22908,United States

Clinical Trial Site

Recruiting

Duarte,California,91010,United States

Clinical Trial Site

Recruiting

New York,New York,10065,United States

Clinical Trial Site

Recruiting

Chicago,Illinois,60611,United States

Clinical Trial Site

Recruiting

Fairfax,Virginia,22031,United States

Clinical Trial Site

Recruiting

Fresno,California,93720,United States

Clinical Trial Site

Recruiting

Philadelphia,Pennsylvania,19144,United States

Clinical Trial Site

Recruiting

New Orleans,Louisiana,70112,United States

Clinical Trial Site

Recruiting

Madison,Wisconsin,53705,United States

Clinical Trial Site

Recruiting

La Jolla,California,92037,United States

Clinical Trial Site

Recruiting

Pittsburgh,Pennsylvania,15232,United States

Clinical Trial Site

Recruiting

Baltimore,Maryland,21204,United States

Worldwide Contacts

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