RecruitingPhase 1Phase 2NCT07136545

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)

Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

HNSCC

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HCB101 in combination with pembrolizumab (an immunotherapy drug) for people with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) — cancer of the mouth, throat, or related structures — that has progressed after standard treatment. **You may be eligible if...** - You are 18 or older - You have confirmed head and neck squamous cell carcinoma - Your cancer came back or spread after, or within 6 months of completing, platinum-based chemotherapy with radiation - You have at least one measurable tumor on imaging - You are in reasonably good health (ECOG 0-1) **You may NOT be eligible if...** - You have not had prior cisplatin-based treatment - You have severe autoimmune disease or are on immunosuppressive medications - You have untreated brain metastases - Your organ function is not adequate for this combination therapy - You have had a prior serious allergic reaction to pembrolizumab or similar drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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