drugset
drugset / Trial / NCT06788990

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

NCT06788990 ↗

Phase 2/3 Recruiting 650 enrolled Bicara Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Timeline

Start
2025-01-28
Primary completion
2028-04
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ficerafusp alfa Protein / enzyme biologic 750 mg —
Subject Ficerafusp alfa Protein / enzyme biologic 1500 mg —
Background Pembrolizumab Monoclonal antibody 200 mg —

Indications

head and neck squamous cell carcinoma