Actively Recruiting
A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by Kyntra Bio · Updated on 2026-05-22
75
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FG-3246, a CD46-targeting antibody-drug conjugate, in men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with one prior second-generation androgen receptor signaling inhibitor but have not received taxane therapy for mCRPC. This Phase 2 study aims to assess the safety, tolerability, pharmacokinetics, and effectiveness of FG-3246 in this patient population. Participants will receive FG-3246 intravenously every 21 days at one of three dose levels: 1.8 mg/kg, 2.4 mg/kg, or 2.7 mg/kg. Treatment continues until disease progression, unacceptable side effects, participant or investigator decision to stop, or study closure by the sponsor. The study includes randomized assignment to dosing groups without masking. During the trial, investigators will monitor radiographic progression-free survival, treatment-emergent adverse events, and drug levels in the blood over approximately 25 months. Additional assessments will include response rates, prostate-specific antigen changes, overall survival, and immune response to the drug. Safety and efficacy measures will be collected regularly, with follow-up visits continuing for up to about two years.
CONDITIONS
Brief 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 or cytological confirmation of prostate adenocarcinoma.
- Participant with soft tissue disease must agree to biopsy of a tumor lesion or provide a suitable archival biopsy.
- Serum testosterone levels must be below 50 ng/dL during screening.
- Participant must have progressed on no more than one prior second-generation androgen receptor signaling inhibitor.
- Participant must have progressive metastatic castration-resistant prostate cancer at screening.
- At least one metastatic lesion must be present on baseline CT, MRI, or bone scan within 28 days before randomization.
- Participant must have adequate organ function during screening.
- Participant must be male and at least 18 years old.
You will not qualify if you...
- Participant has received previous treatment targeting CD46.
- Participant has small cell neuroendocrine carcinoma on any prior histologic evaluation.
- Participant has progressed on more than one prior second-generation androgen receptor signaling inhibitor or received more than two in any setting.
- Participant has received recent anticancer treatments before enrollment, except ongoing supportive or hormonal therapies started well before randomization.
- Participant has received radiation therapy within 14 days prior to randomization.
- Participant has a known actionable gene mutation with available approved therapies unless unsuitable or refused.
- Participant has Grade 2 or higher peripheral neuropathy at screening.
- Participant has received prior chemotherapy; one prior taxane chemotherapy in the castration-sensitive setting is allowed if completed over 12 months before randomization.
- Participant has known hypersensitivity to FG-3246 components or related antibodies.
- Participant has had any other malignancy in the past 5 years except treated basal or squamous cell skin carcinoma.
- Participant requires treatment with strong CYP3A4 inhibitors or inducers that cannot be stopped.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until radiographic progression or discontinuation (up to approximately 25 months)
Participants receive FG-3246 via intravenous infusion on Day 1 of each 21-day treatment cycle until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, or other withdrawal criteria are met.
1 visit every 3 weeks (in-person) for infusion
Trial Site Locations
Total: 20 locations
1
Western Regional Medical Center - City of Hope Phoenix Goodyear
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
4
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
5
UCLA Clark Urology Center
Los Angeles, California, United States, 90095
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
7
New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
8
Bioresearch Partner - Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
9
Bioresearch Partner - Hialeah
Hialeah, Florida, United States, 33013
Actively Recruiting
10
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
East Jefferson General Hospital Metairie
New Orleans, Louisiana, United States, 70112
Actively Recruiting
12
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
13
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
14
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
15
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
16
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
17
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
18
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
19
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
J
Javier Moreno
M
Mairead Carney
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here