# FORTIFI-HN01

Source: https://onco.cc/trials/fortifi-hn01/  
OnCo record `fortifi-hn01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A bifunctional antibody that blocks EGFR and soaks up TGF-beta, aiming to make HPV-negative head and neck tumours respond to immunotherapy.

## Summary

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-07
- Registry id: NCT06788990
- Phase: 2/3
- Setting: Untreated PD-L1-positive, HPV-negative recurrent or metastatic HNSCC: ficerafusp alfa + pembrolizumab vs pembrolizumab
- Sponsor: Bicara Therapeutics

## Sources

- ClinicalTrials.gov NCT06788990: https://clinicaltrials.gov/study/NCT06788990
- Phase 1/1b two-year results, JCO 2025: https://ascopubs.org/doi/10.1200/JCO-25-02027

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Ficerafusp alfa](https://onco.cc/drugs/ficerafusp-alfa/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Bicara Therapeutics](https://onco.cc/companies/bicara-therapeutics/)
- pairings: [EGFR-directed bispecific + PD-1 blockade](https://onco.cc/pairings/egfr-bispecific-plus-pd1-hnscc/)

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