Condition: HNSCC · Sponsor: Taipei Veterans General Hospital, Taiwan
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.
This description comes directly from the study's public registry record.
Iris chang · +886-2-2871-2121 · iris.c8987223@protonmail.com
Always discuss trial participation with your own doctor first.
| Chang-Gung Memorial Hospital(Lin-Kou) | Taoyuan, Guishan District, Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei, Taipei City, Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei, Taipei City, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07136545