RecruitingRecruiting
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT06842498 · Kyntra Bio
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
About this study
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 criteria
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.
Study design
Enrollment target: 75 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-22
Estimated completion: 2028-03-31
Last updated: 2026-05-22
Interventions
Drug: FG-3246
Primary outcomes
- • 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))
Sponsor
Kyntra Bio · industry
Contacts & investigators
ContactJavier Moreno · contact · jmoreno@kyntrabio.com · 415-978-1466
ContactMairead Carney · contact · mcarney@kyntrabio.com · 415-978-1337
All locations (20)
Western Regional Medical Center - City of Hope Phoenix GoodyearRecruiting
Goodyear, Arizona, United States
HonorHealth Research InstituteRecruiting
Scottsdale, Arizona, United States
The University of Arizona Cancer Center - North CampusRecruiting
Tucson, Arizona, United States
VA Greater Los Angeles Healthcare SystemRecruiting
Los Angeles, California, United States
UCLA Clark Urology CenterRecruiting
Los Angeles, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
New Haven Hospital - Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Bioresearch Partner - AventuraRecruiting
Aventura, Florida, United States
Bioresearch Partner - HialeahRecruiting
Hialeah, Florida, United States
Winship Cancer Institute, Emory UniversityRecruiting
Atlanta, Georgia, United States
East Jefferson General Hospital MetairieRecruiting
New Orleans, Louisiana, United States
New Mexico Oncology Hematology Consultants, Ltd.Recruiting
Albuquerque, New Mexico, United States
Duke University Medical Center - Duke Cancer CenterRecruiting
Durham, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Oncology ConsultantsRecruiting
Houston, Texas, United States
University of Virginia Comprehensive Cancer CenterRecruiting
Charlottesville, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States