{"entity":{"id":"fortifi-hn01","kind":"trial","name":"FORTIFI-HN01","aka":[],"tldr":"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.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06788990","url":"https://clinicaltrials.gov/study/NCT06788990"},{"label":"Phase 1/1b two-year results, JCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO-25-02027"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["egfr"],"drugs":["ficerafusp-alfa","pembrolizumab"],"companies":["bicara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06788990","phase":"2/3","setting":"Untreated PD-L1-positive, HPV-negative recurrent or metastatic HNSCC: ficerafusp alfa + pembrolizumab vs pembrolizumab","sponsor":"Bicara Therapeutics","participation":[{"nct":"NCT06788990","source":"https://clinicaltrials.gov/study/NCT06788990","fetchedAt":"2026-10-07T16:55:03.017Z","studySha256":"60671b14f59874873a5f9cf41a8bcdae888e4f6746938bfad869c3edf5ca2551","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-02","leadSponsor":"Bicara Therapeutics","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":650,"enrolmentType":"ESTIMATED","siteCount":231,"recruitingSiteCount":231,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","Czechia","France","Germany","Greece","India","Ireland","Israel","Italy","Japan","Malaysia","New Zealand","Poland","Portugal","Singapore","South Korea","Spain","Switzerland","Taiwan","Thailand","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2025-01-28","startedType":"actual","enrolledBasis":"registry","outcomes":[]},"route":"/trials/fortifi-hn01/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"ficerafusp-alfa","kind":"drug","name":"Ficerafusp alfa","route":"/drugs/ficerafusp-alfa/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"bicara-therapeutics","kind":"company","name":"Bicara Therapeutics","route":"/companies/bicara-therapeutics/"}],"pairing":[{"id":"egfr-bispecific-plus-pd1-hnscc","kind":"pairing","name":"EGFR-directed bispecific + PD-1 blockade","route":"/pairings/egfr-bispecific-plus-pd1-hnscc/"}]}}