Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC
Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients With trop2 and CPS Positive: A Prospective, Single Arm, Phase II Trial
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
39 participants
Jul 31, 2025
INTERVENTIONAL
Conditions
Summary
This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of Sacituzumab Tirumotecan and Toripalimab in the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients with trop2 and CPS positive. The participants would receive Sacituzumab Tirumotecan and Toripalimab until termination criteria are met.
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
The dosing regimen for the combination of Sacituzumab Tirumotecan and Toripalimab is as follows: the recommended dose of Sacituzumab Tirumotecan is 5mg/kg, administered intravenously every 2 weeks, and Toripalimab is administered intravenously (without prophylactic medication), with a fixed dose of 240mg, and 3mg/kg is used for subjects with baseline body weight\<50kg. Each infusion lasts for 30 minutes (not less than 20 minutes, not more than 60 minutes), administered once every 2 weeks. The subjects will continue to receive combination therapy with Sacituzumab Tirumotecan and Toripalimab until the termination criteria are met.
Locations(1)
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NCT07088211