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NCT06842498PHASE2Recruiting

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

Kyntra Bio

Start Date

2/22/2026

Completion Date

3/31/2028

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies. * Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable archival biopsy of a primary or metastatic lesion. * Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening. * Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting. * Participant must have progressive mCRPC following last treatment at screening. * Participant must have ≥1 metastatic lesion that is present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤28 days prior to randomization. * Participant must have adequate organ function during screening. Key Exclusion Criteria: * Participant has received previous treatment with a therapeutic targeting CD46. * Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion. * Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting. * Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change. * Participant has received any prior radiation therapy within 14 days prior to randomization. * Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. * Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology. * Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed \>12 months before randomization. * Participant has known hypersensitivity to the components of FG-3246 or its analogs or a history of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies. * Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin. * Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued. NOTE: Other protocol-defined inclusion/exclusion may apply.

Interventions

DRUG

FG-3246

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Conditions

Metastatic Castration-Resistant Prostate Cancer

Locations

Western Regional Medical Center - City of Hope Phoenix Goodyear

Goodyear, Arizona 85338

United States

HonorHealth Research Institute

Scottsdale, Arizona 85258

United States

The University of Arizona Cancer Center - North Campus

Tucson, Arizona 85719

United States

VA Greater Los Angeles Healthcare System

Los Angeles, California 90073

United States

UCLA Clark Urology Center

Los Angeles, California 90095

United States

University of California San Francisco

San Francisco, California 94158

United States

New Haven Hospital - Yale Cancer Center

New Haven, Connecticut 06519

United States

Bioresearch Partner - Aventura

Aventura, Florida 33180

United States

Bioresearch Partner - Hialeah

Hialeah, Florida 33013

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

East Jefferson General Hospital Metairie

New Orleans, Louisiana 70112

United States

New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico 87109

United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina 27710

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Oncology Consultants

Houston, Texas 77030

United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia 22908

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center

Seattle, Washington 98195

United States