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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

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. - Participant with safely accessible tumor lesion must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide an archival biopsy of a primary or metastatic lesion that was taken after castration resistance developed and within 1 year prior to randomization. - Participant must have serum testosterone levels <50 nanograms (ng)/deciliter (dL) during screening. - Participant is required to have progressed on 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 and reconfirmed on Study Day -1 or Day 1.

Exclusion Criteria

  • 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 of primary or metastatic lesion. - Participant has received more than one prior second-generation ARSI in any setting. - Participant has received any systemic anticancer therapy (for example, hormonal therapy, chemotherapy, immunotherapy, radioligand therapy, or biological therapy [including monoclonal antibodies], including investigational 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, 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

ArmDescriptionAssigned 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 FibroGen decision to close the study.
  • Drug: FG-3246
    FG-3246 will be administered per schedule specified in the arm description.
    Other names:
    • FOR46
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 FibroGen decision to close the study.
  • Drug: FG-3246
    FG-3246 will be administered per schedule specified in the arm description.
    Other names:
    • FOR46
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 FibroGen decision to close the study.
  • Drug: FG-3246
    FG-3246 will be administered per schedule specified in the arm description.
    Other names:
    • FOR46

Recruiting Locations

The University of Arizona Cancer Center - North Campus
Tucson 5318313, Arizona 5551752 85719

UCLA Clark Urology Center
Los Angeles 5368361, California 5332921 90095

University of California San Francisco
San Francisco 5391959, California 5332921 94143

Bioresearch Partner
Aventura 4146429, Florida 4155751 33180

Bioresearch Partner
Hialeah 4158476, Florida 4155751 33013

Winship Cancer Institute, Emory University
Atlanta 4180439, Georgia 4197000 30322

UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514

Duke University Medical Center - Duke Cancer Center
Durham 4464368, North Carolina 4482348 27710

Carolina Urologic Research Center
Myrtle Beach 4588718, South Carolina 4597040 29572

University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Oncology Consultants
Houston 4699066, Texas 4736286 77030

University of Virginia Comprehensive Cancer Center
Charlottesville 4752031, Virginia 6254928 22903

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

More Details

Status
Recruiting
Sponsor
Kyntra Bio

Study Contact

Javier Moreno
415-978-1466
jmoreno@kyntrabio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.