A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06842498
Protocol IDs
FGCL-3246-112 (primary)
NCI-2025-01692
Study Sponsor
Kyntra Bio

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

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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.