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A bifunctional antibody that blocks EGFR and soaks up TGF-beta, aiming to make HPV-negative head and neck tumours respond to immunotherapy.
FORTIFI-HN01, trial NCT06788990 sponsored by Bicara Therapeutics, tests ficerafusp alfa, a bifunctional antibody that blocks EGFR and soaks up TGF-beta, with pembrolizumab against pembrolizumab alone in untreated PD-L1-positive, HPV-negative recurrent or metastatic head and neck cancer. Two-year phase 1/1b data published in JCO in 2025 reported durable responses in HPV-negative disease, the phase 3 dose is fixed at 1500 mg, and Bicara expects substantial enrolment by the end of 2026 with an interim analysis in mid-2027; unlike LiGeR-HN1 it excludes HPV-positive oropharyngeal cancer. OnCo links it to head and neck cancer, bispecific antibodies, EGFR as a target, ficerafusp alfa, pembrolizumab and the pairing of an EGFR-directed bispecific with PD-1 blockade. Whether trapping TGF-beta makes cold HPV-negative tumours respond to immunotherapy is the question it will answer.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Bicara Therapeutics, Ficerafusp alfa, Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies.
Shares EGFR-directed bispecific + PD-1 blockade, Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies, EGFR.
Shares EGFR-directed bispecific + PD-1 blockade, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, Head and neck squamous cell carcinoma.
Shares Recurrent or metastatic head and neck squamous cell carcinoma, Head and neck squamous cell carcinoma, Pembrolizumab.
Shares Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies, Head and neck squamous cell carcinoma.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, EGFR, Head and neck squamous cell carcinoma.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, EGFR, Head and neck squamous cell carcinoma.
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