OncoMatch/Clinical Trials/NCT07136545
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)
Is NCT07136545 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including HCB101 and Pembrolizumab for hnscc.
Treatment: HCB101 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
With progression after 1st cisplatin based therapy for R/M HNSCC or within 6 months after cisplatin based CCRT
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cisplatin-based therapy (cisplatin) — recurrent/metastatic or concurrent chemoradiotherapy
With progression after 1st cisplatin based therapy for R/M HNSCC or within 6 months after cisplatin based CCRT
Cannot have received: systemic cancer therapy
any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternative therapies with anti-cancer indications or targeted therapy) within 14 days or 5 half lives, whichever is longer, prior to the first dose of the study intervention
Cannot have received: CD47 or SIRPA pathway inhibitor
received any treatment targeting the CD47 or SIRPα pathway
Cannot have received: anti-PD-1 therapy (pembrolizumab)
previously received pembrolizumab treatment
Cannot have received: live vaccine
received a live vaccine within 30 days prior to pembrolizumab administration
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L; Platelets ≥75 × 10^9/L; Hemoglobin ≥9.5 g/dL
Kidney function
Creatinine clearance ≥50 mL/min (using Cockcroft Gault equation)
Liver function
Total bilirubin ≤1.5 × ULN, <3.0 × ULN if known Gilbert's disease; ALT and AST ≤3× ULN and ≤5× ULN for subject with liver metastasis
Cardiac function
No clinically significant cardiovascular condition (see exclusion criteria); QTcF >470 msec at Screening excluded
Have adequate organ function, as indicated by the following laboratory parameters... (see inclusion criterion 8 and exclusion criteria for cardiac details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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