Ficerafusp alfa — Investigational Agent
Monoclonal Antibody · Phase 2/3 · Bicara Therapeutics
Mechanism of Action
Bifunctional (bispecific) fusion protein combining an anti-EGFR monoclonal antibody with a TGF-β "trap" (TGF-βRII ectodomain). It simultaneously blocks EGFR oncogenic signaling on tumor cells and sequesters TGF-β in the tumor microenvironment. Neutralizing TGF-β reverses immunosuppression and may enhance response to PD-1 blockade, addressing a key resistance pathway in HNSCC.
Investigational Indications
- Recurrent/metastatic PD-L1–positive head and neck squamous cell carcinoma (HNSCC)
- Other EGFR-driven advanced solid tumors