FORTIFI-HN01
A bifunctional antibody that blocks EGFR and soaks up TGF-beta, aiming to make HPV-negative head and neck tumours respond to immunotherapy.
Phase 1/1b two-year data (JCO 2025) reported durable responses in HPV-negative disease. Phase 3 dose fixed at 1500 mg; Bicara expects substantial enrolment by end-2026 and an interim analysis in mid-2027. Excludes HPV-positive oropharyngeal cancer, unlike LiGeR-HN1.
Setting
Untreated PD-L1-positive, HPV-negative recurrent or metastatic HNSCC: ficerafusp alfa + pembrolizumab vs pembrolizumab
Phase
Phase 2/3
Sponsor
Bicara Therapeutics
Registry
Pages like this
not linked directly; found by shared links- TrialLiGeR-HN1
Shares EGFR-directed bispecific + PD-1 blockade, Bispecific antibodies, EGFR, Pembrolizumab.
- ProductPetosemtamab
Shares EGFR-directed bispecific + PD-1 blockade, Bispecific antibodies, EGFR, Pembrolizumab.
- ProductCetuximab sarotalocan
- TrialEXTREME
- PersonJohn V. Heymach
- PersonKumar Prabhash
- TrialKEYNOTE-048
Shares Pembrolizumab, Head and neck squamous cell carcinoma.
- PairingImmunotherapy before surgery rather than with chemoradiation (HNSCC)
Shares Pembrolizumab, Head and neck squamous cell carcinoma.