Bicara Therapeutics Inc. initiates Phase 3 trial with 1500 mg QW dose for FORTIFI-HN01

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Olga Shendetskaya

30.03.2026

Bicara Therapeutics Inc. initiates Phase 3 trial with 1500 mg QW dose for FORTIFI-HN01 — Bicara starts Phase 3 HNSCC trial

Bicara Therapeutics Inc. has launched a Phase 3 clinical trial, selecting a 1500 mg once weekly (QW) dosage for its FORTIFI-HN01 program targeting patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).

The company has also begun advancing a Q3W (every three weeks) maintenance strategy and initiated the study for first-line recurrent or metastatic (1L R M) HPV-negative HNSCC patients. Bicara Therapeutics Inc. plans to discuss these updates during a scheduled conference call today at 8:30 a.m. ET.

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Bicara has previously focused on research to address fibrotic and resistant HPV-negative solid tumors, including initiatives outlined in its tumor resistance program. The company has also highlighted engagement efforts to build enduring patient trust through advocacy and community projects, according to prior statements. These efforts continue alongside clinical development for HPV-negative HNSCC.

This material may contain third-party opinions, none of the data and information on this webpage constitutes investment advice according to our Disclaimer. While we adhere to strict Editorial Integrity, this post may contain references to products from our partners.

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