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 (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT07136545 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic cancer therapy, CD47 or SIRPA pathway inhibitor, anti-PD-1 therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages