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)
Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria — Until radiographic progression is noted (up to approximately 25 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) — From first dose until 28 days after last dose (up to approximately 25 months)
Maximum Plasma Concentration (Cmax) of FG-3246, Total Anti-cluster of Differentiation 46 Antibody (CD46), and Free Monomethyl Auristatin E (MMAE) — Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
Trial sites (23)
Facility
City
Region
Status
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.