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Clinical Trials in the USA / NCT06842498
Recruiting Phase 2

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

NCT06842498 · tracked via the Priya Life Science USA tracker
Sponsor
Kyntra Bio
Phase
Phase 2
Started
2026-02-22
Last updated
2026-08-17

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

FG-3246

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

Study 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
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Western Regional Medical Center - City of Hope Phoenix Goodyear Goodyear Arizona Recruiting
HonorHealth Research Institute Scottsdale Arizona Recruiting
The University of Arizona Cancer Center - North Campus Tucson Arizona Recruiting
VA Greater Los Angeles Healthcare System Los Angeles California Recruiting
UCLA Clark Urology Center Los Angeles California Recruiting
University of California San Francisco San Francisco California Recruiting
New Haven Hospital - Yale Cancer Center New Haven Connecticut Recruiting
Bioresearch Partner - Aventura Aventura Florida Recruiting
Bioresearch Partner - Hialeah Hialeah Florida Recruiting
Biogenix Molecular, LLC Miami Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
East Jefferson General Hospital Metairie New Orleans Louisiana Recruiting
New Mexico Oncology Hematology Consultants, Ltd. Albuquerque New Mexico Recruiting
Duke University Medical Center - Duke Cancer Center Durham North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina Recruiting
Henry-Joyce Cancer Clinic Nashville Tennessee Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Oncology Consultants Houston Texas Recruiting
University of Virginia Comprehensive Cancer Center Charlottesville Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
University of Washington Medical Center Seattle Washington Recruiting
Northwest Medical Specialties, PLLC - Tacoma Tacoma Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06842498 on ClinicalTrials.gov ↗ ← All trials in the USA