FibroGen (FGEN) announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate, ADC, targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer, mCRPC. The trial will also assess the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 will be evaluated. In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025.
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