Who is sponsoring FORTIFI-HN01?

FORTIFI-HN01 is sponsored by Bicara Therapeutics.

What condition does FORTIFI-HN01 study?

FORTIFI-HN01 studies Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma.

What drugs are being tested in FORTIFI-HN01?

Interventions: Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo.

What is the status of FORTIFI-HN01?

FORTIFI-HN01 is currently RECRUITING.

Last reviewed 2026-05-12 · How we verify

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01)

NCT06788990 Phase 2/Phase 3 RECRUITING

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Details

Lead sponsor	Bicara Therapeutics
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	650
Start date	2025-01-28
Completion	2029-07

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Ficerafusp alfa
Pembrolizumab (KEYTRUDA®)
Placebo

Primary outcomes

Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation. — Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) — Approximately 1 year.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR. — Approximately 2 years.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
Phase 3 - Overall Survival (OS) — Approximately 3 years.
OS: Defined as the time from the randomization to death due to any cause.

Countries

United States, Argentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Ireland, Italy, Malaysia, New Zealand, Poland, Portugal, Singapore, South Korea, Spain, United Kingdom