Study of HCB101 Combined With Pembrolizumab for Adults With Platinum-Resistant Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This research aims to evaluate the safety, tolerability, and efficacy of the drug HCB101 combined with pembrolizumab in adults with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma HNSCC. This phase III clinical trial includes a dose-escalation phase to find the best dose and a dose-expansion phase to further assess treatment effects. Participants receive weekly intravenous infusions of HCB101 over about 60 minutes on Days 1, 8, and 15 of each 21-day cycle, alongside pembrolizumab 200 mg IV on Day 1 every 21 days. Treatment continues until unacceptable side effects, disease progression, withdrawal, loss to follow-up, death, or study end. The combination therapy is carefully monitored throughout the trial. During the study, participants undergo regular evaluations including safety and effectiveness assessments. Researchers track adverse events, tumor response rates, progression-free survival, and quality of life using questionnaires. Participants are followed for up to two years to measure outcomes and monitor overall health, ensuring comprehensive safety oversight and ongoing data collection.

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)