Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

BOSTON, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β).