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RECRUITINGPHASE2

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

NCT06842498•Kyntra Bio

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma.
•Participant with safely accessible tumor lesion must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide an archival biopsy of a primary or metastatic lesion that was taken after castration resistance developed and within 1 year prior to randomization.
•Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening.
•Participant is required to have progressed on 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 and reconfirmed on Study Day -1 or Day 1.

Exclusion Criteria

•Participant has received previous treatment with a therapeutic targeting CD46.
•Participant has small cell neuroendocrine carcinoma (pure or mixed) or any other non-adenocarcinoma component on prior or current histologic evaluation of primary or metastatic lesion.
•Participant has received more than one prior second-generation ARSI in any setting.
•Participant has received any systemic anticancer therapy (for example, hormonal therapy, chemotherapy, immunotherapy, radioligand therapy, or biological therapy \[including monoclonal antibodies\], including investigational therapy) within 28 days prior to randomization.
•Participant has received any prior radiation therapy within 28 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.
+2 more criteria

Locations (15)

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

UCLA Clark Urology Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Bioresearch Partner

Aventura, Florida, United States

Bioresearch Partner

Hialeah, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico, United States

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Key Dates

Start Date

February 22, 2026

Primary Completion Date

March 31, 2028

Completion Date

March 31, 2028

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

FG-3246

DRUG

Contacts

Javier Moreno

CONTACT

415-978-1466 jmoreno@kyntrabio.com

Mairead Carney

CONTACT

415-978-1337 mcarney@kyntrabio.com

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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RECRUITINGPHASE2

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

NCT07476001

Metastatic Castration-resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

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A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer