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Back|NCT06842498Recruiting
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

Phase
Phase 2
Sponsor
FibroGen
Enrollment
75
Timeline
Jan 2026 → Mar 2028
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

Inclusion Criteria

  • 1Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma.
  • 2Participant 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.
  • 3Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening.
  • 4Participant 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.
  • 5Participant must have progressive mCRPC following last treatment at screening.
  • 6Participant 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.
  • 7Participant must have adequate organ function during screening and reconfirmed on Study Day -1 or Day 1.

Exclusion Criteria

  • 1Participant has received previous treatment with a therapeutic targeting CD46.
  • 2Participant 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.
  • 3Participant has received more than one prior second-generation ARSI in any setting.
  • 4Participant 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.
  • 5Participant has received any prior radiation therapy within 28 days prior to randomization.
  • 6Participant 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.
  • 7Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology.
  • 8Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed \>12 months before randomization.
  • 9Participant 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.
  • 10Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin.
  • 11Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued.
  • 12NOTE: Other protocol-defined inclusion/exclusion may apply.

Locations

4 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

University of California San Francisco

San Francisco, California 94143

Recruiting

University of Texas Southwestern Medical Center

Dallas, Texas 75390

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →