A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Purpose
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.
Condition
- Metastatic Castration-Resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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.
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental FG-3246 1.8 mg/kg |
Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks [Q3W]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
|
|
Experimental FG-3246 2.4 mg/kg |
Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
|
|
Experimental FG-3246 2.7 mg/kg |
Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
|
Recruiting Locations
Western Regional Medical Center - City of Hope Phoenix Goodyear
Goodyear, Arizona 85338
Goodyear, Arizona 85338
HonorHealth Research Institute
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
The University of Arizona Cancer Center - North Campus
Tucson, Arizona 85719
Tucson, Arizona 85719
VA Greater Los Angeles Healthcare System
Los Angeles, California 90073
Los Angeles, California 90073
UCLA Clark Urology Center
Los Angeles, California 90095
Los Angeles, California 90095
University of California San Francisco
San Francisco, California 94158
San Francisco, California 94158
New Haven Hospital - Yale Cancer Center
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Bioresearch Partner - Aventura
Aventura, Florida 33180
Aventura, Florida 33180
Bioresearch Partner - Hialeah
Hialeah, Florida 33013
Hialeah, Florida 33013
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
East Jefferson General Hospital Metairie
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina 27710
Durham, North Carolina 27710
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Oncology Consultants
Houston, Texas 77030
Houston, Texas 77030
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
More Details
- Status
- Recruiting
- Sponsor
- Kyntra Bio