RecruitingPhase 2NCT04986423

ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer

A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor

Zenith Epigenetics

Enrollment

200 participants

Start Date

Sep 8, 2021

Study Type

INTERVENTIONAL

Summary

This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry. The patient population will be separated into two cohorts: Cohort A: Patients with poor response to prior abiraterone defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone Cohort B: Patients with response to prior abiraterone, defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding ZEN003694 — a new drug that targets a protein involved in cancer growth — to enzalutamide (a standard hormone therapy) works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) that stopped responding to abiraterone. **You may be eligible if...** - You are male and 18 or older - You have metastatic castration-resistant prostate cancer (cancer has spread and no longer responds to hormone deprivation) - You have been on testosterone-lowering therapy (surgical or medical) for at least 8 weeks - Your prostate cancer previously progressed on abiraterone - You are not a candidate for or have declined chemotherapy **You may NOT be eligible if...** - You have brain metastases or a history of seizures - You have received prior enzalutamide or similar drug (e.g., apalutamide) - You have significant heart problems or uncontrolled blood pressure - You have active infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZEN003694

72 mg PO QD

DRUGEnzalutamide

160 mg PO QD

Locations(31)

California Research Institute

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

Colorado Urology

Lakewood, Colorado, United States

D&H Cancer Research Center, LLC

Margate, Florida, United States

BRCR Global

Plantation, Florida, United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

Messino Cancer Center

Asheville, North Carolina, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Urology Associates, P.C.

Nashville, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Anhui Provincial Hospital

Hefei, Anhui, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotang University

Xi'an, Shaanxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT04986423