Kyntra Bio
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.
Key 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…
FG-3246 will be administered per schedule specified in the arm description.