Actively Recruiting
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Led by Kyntra Bio · Updated on 2026-03-20
75
Participants Needed
15
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or provide an archival biopsy taken after castration resistance developed and within 1 year prior to randomization.
- Participant must have serum testosterone levels less than 50 ng/dL during screening.
- Participant must have progressed on one prior second-generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting.
- Participant must have progressive metastatic castration-resistant prostate cancer following last treatment at screening.
- Participant must have at least one metastatic lesion present on baseline CT, MRI, or bone scan obtained within 28 days prior to randomization.
- Participant must have adequate organ function during screening and reconfirmed on Study Day -1 or Day 1.
You will not qualify if you...
- 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.
- Participant has received more than one prior second-generation ARSI in any setting.
- Participant has received any systemic anticancer 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, such as BRCA1 mutation, for which approved therapies are available unless deemed inappropriate or refused.
- Participant has Grade 2 or higher peripheral neuropathy at screening.
- Participant has received any prior chemotherapy for mCRPC; one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed more than 12 months before randomization.
- Participant has known hypersensitivity to FG-3246 components or has had allergic reactions to similar monoclonal antibodies.
- Participant has had 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 CYP3A4 inhibitor or inducer drug that cannot be safely stopped.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
2
UCLA Clark Urology Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Bioresearch Partner
Aventura, Florida, United States, 33180
Actively Recruiting
5
Bioresearch Partner
Hialeah, Florida, United States, 33013
Actively Recruiting
6
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
8
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
12
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
15
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Javier Moreno
CONTACT
M
Mairead Carney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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