A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)

This is a non-randomized, open-label, dose-escalation and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II). Subjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with pembrolizumab (200 mg IV day 1; given every 21 days) until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.

NCT Number	NCT07136545
Lead Sponsor	Taipei Veterans General Hospital, Taiwan Collaborators: FBD Biologics Limited, National Taiwan University Hospital, Chang Gung Memorial Hospital
Conditions	HNSCC
Enrollment	50 participants
Start Date	2025-08-13
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-06