Phase 2 ficerafusp alfa (BCA101) EGFR×TGF-β bifunctional antibody + pembrolizumab

Bicara Therapeutics is running a multicenter, open-label Phase 2 study in first-line PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma testing maintenance dosing strategies for ficerafusp alfa (BCA101) in combination with pembrolizumab. Ficerafusp alfa is a bifunctional EGFR-targeting antibody with a TGF-β trap designed to combine EGFR pathway inhibition with local relief of TGF-β–mediated immune suppression. All participants initially receive ficerafusp alfa 1500 mg weekly with pembrolizumab every 3 weeks for a 12-week loading period. Patients who remain on study without progression then enter the maintenance phase and are randomized 2:1 to ficerafusp alfa 2250 mg every 3 weeks or continued 1500-mg weekly dosing, with pembrolizumab every 3 weeks in both groups. The central question is whether less-frequent maintenance dosing can preserve antitumor activity while reducing infusion burden and improving real-world treatment convenience. Current first-line care for PD-L1–positive recurrent/metastatic HNSCC includes pembrolizumab alone or pembrolizumab with chemotherapy depending on disease burden and clinical circumstances; this study tests whether adding dual EGFR/TGF-β targeting can deepen or extend benefit while finding a more practical long-term dosing schedule.