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 not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent rozumie i zgadza się wziąć udział w badaniu, w tym przestrzegać jego zasad.
- •Pacjent ma co najmniej 18 lat.
- •U pacjenta potwierdzono raka płaskonabłonkowego głowy i szyi.
- •Rak pacjenta nawrócił lub rozprzestrzenił się po leczeniu chemioterapią lub chemioradioterapią.
- •Pacjent ma przynajmniej jedną zmianę nowotworową, którą można zmierzyć.
- •Stan ogólny pacjenta pozwala na udział w badaniu (oceniany w skali ECOG 0-2).
- •Przewidywana długość życia pacjenta wynosi co najmniej 12 tygodni.
- •Narządy pacjenta działają prawidłowo, co potwierdzają wyniki badań krwi.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
Chang-Gung Memorial Hospital(Lin-Kou)
Taoyuan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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