RecruitingPhase 2NCT07088211

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


Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Enrollment

39 participants

Start Date

Jul 31, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two new cancer drugs — sacituzumab tirumotecan (an antibody-drug conjugate) and toripalimab (an immunotherapy drug) — as a first-line treatment for people with head and neck squamous cell carcinoma (cancer of the mouth, throat, or voice box) that cannot be cured with surgery or radiation. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, or larynx) - This is your first time receiving systemic treatment for advanced/metastatic disease - Your cancer cannot be cured with surgery or radiation - You have adequate organ function **You may NOT be eligible if...** - You have previously received systemic treatment for advanced/metastatic head and neck cancer - You have autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have uncontrolled infections or certain other cancers Talk to your doctor to see if this trial is right for you.

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

DRUGSacituzumab Tirumotecan and Toripalimab

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)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT07088211


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