Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Phase 1 Recruiting 292 enrolled Bicara Therapeutics Merck Sharp & Dohme LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Timeline

Start: 2020-06-01
Primary completion: 2026-12-31
Completion: 2027-06-01

Publications

Hanna GJ, Zandberg DP, Wong DJ, Sherman E, Sacco AG, Yilmaz E, Hernando-Calvo A, Reiners RD, Bohr D, Salazar RL, O'Connell BC, Raben D, Schulten J, Chung CH, Kaczmar J. Ficerafusp Alfa (BCA101) With Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Two-Year Results of an Expansion Cohort of a Phase I/Ib Trial. J Clin Oncol. 2026 Jun 20;44(18):1697-1708. doi: 10.1200/JCO-25-02027. Epub 2026 May 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ficerafusp alfa	Protein / enzyme biologic	1500 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications