RecruitingPhase 2NCT06842498

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor

Kyntra Bio

Enrollment

75 participants

Start Date

Feb 22, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called FG-3246 for men with metastatic castration-resistant prostate cancer (mCRPC) — prostate cancer that has spread and continues to grow even when testosterone levels are very low. FG-3246 is designed to target a specific protein on prostate cancer cells, delivering a payload that kills the cancer cell. **You may be eligible if...** - You have been diagnosed with prostate adenocarcinoma that has spread (metastatic) and is castration-resistant - Your testosterone is very low (under 50 ng/dL) - You have already received one prior treatment with a second-generation hormonal therapy (such as enzalutamide, abiraterone, apalutamide, or darolutamide) - You are willing to provide a tumor biopsy during the study screening period **You may NOT be eligible if...** - You have received more than one prior line of systemic therapy for castration-resistant disease - You have had prior treatment with certain other classes of drugs - You have significant heart, liver, or kidney problems - You are on other investigational treatments 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

DRUGFG-3246

FG-3246 will be administered per schedule specified in the arm description.

Locations(20)

Western Regional Medical Center - City of Hope Phoenix Goodyear

Goodyear, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

UCLA Clark Urology Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States

Bioresearch Partner - Aventura

Aventura, Florida, United States

Bioresearch Partner - Hialeah

Hialeah, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

East Jefferson General Hospital Metairie

New Orleans, Louisiana, United States

New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico, United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Oncology Consultants

Houston, Texas, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06842498

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