First Patients Enrolled in FORTIFI-HN01, Ph 2/3 Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
“This is a key milestone for Bicara and represents our transition into a late-stage clinical development company,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “Supported by encouraging interim Phase 1/1b data, which demonstrated durable and clinically meaningful anti-tumor activity with ficerafusp alfa in combination with pembrolizumab, FORTIFI-HN01 will evaluate the potential of ficerafusp alfa as a first-in-class treatment option for patients with advanced head and neck squamous cell carcinoma. The thoughtful and efficient design of this trial underscores our strategic approach to rapidly advancing treatment options for these patients, with the goal of addressing the significant unmet needs in this challenging disease.”
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