drugset
drugset / Trial / NCT07807163

A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC

NCT07807163 ↗

Phase 2 Recruiting 160 enrolled Bicara Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Timeline

Start
2026-09
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ficerafusp alfa Protein / enzyme biologic 1500 mg —
Subject Ficerafusp alfa Protein / enzyme biologic 2250 mg —
Background Pembrolizumab Monoclonal antibody 200 mg —

Indications

head and neck squamous cell carcinoma