Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC

PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2028

Conditions
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Sacituzumab 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.

Trial Locations (1)

200011

RECRUITING

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

All Listed Sponsors
lead

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

OTHER

NCT07088211 - Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC | Biotech Hunter | Biotech Hunter