A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate Cancer
Unknown Primary
18 Years and older, Male and Female
FGCL-3246-112 (primary)
NCI-2025-01692
Summary
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
- 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
Treatment Sites in Georgia
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