A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
120 participants
Jul 27, 2026
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.
Eligibility
Plain Language Summary
Simplified for easier understanding
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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Interventions
q3w
Pembrolizumab will be administered by intravenous infusion at a dose of 200 mg on Day 1 of each 3-week cycle, for a maximum treatment duration of 35 cycles (approximately 24 months).
Carboplatin will be administered by intravenous infusion at a dose of AUC 5 mg/mL/min on Day 1 of each 3-week cycle (maximum dose of carboplatin not to exceed 750 mg), for a maximum of 6 cycles.
Cisplatin will be administered by intravenous infusion at a dose of 75 mg/m2 on Day 1 of each 3-week cycle, for a maximum of 6 cycles.
Locations(2)
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NCT07668154