● Recruiting

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Condition: Metastatic Head and Neck Squamous Cell Carcinoma · Recurrent Head and Neck Squamous Cell Carcinoma · Sponsor: Bicara Therapeutics

PhasePhase 2/Phase 3

Planned participants650

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Medical Affairs · 1-617-468-4219 · FORTIFI_inquiries@bicara.com

Always discuss trial participation with your own doctor first.

Locations (203)

Site # 0137	Birmingham, Alabama, United States	Recruiting
Site #0147	Phoenix, Arizona, United States	Recruiting
Site #0107	La Jolla, California, United States	Recruiting
Site #0106	Los Angeles, California, United States	Recruiting
Site#0144	Sacramento, California, United States	Recruiting
Site #0130	San Francisco, California, United States	Recruiting
Site #0150	Stanford, California, United States	Recruiting
Site #0122	Aurora, Colorado, United States	Recruiting
Site #0124	Aurora, Colorado, United States	Recruiting
Site#0121	Aurora, Colorado, United States	Recruiting
Site #0148	Jacksonville, Florida, United States	Recruiting
Site #0136	Palm Bay, Florida, United States	Recruiting

+ 191 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06788990