RecruitingPhase 2NCT07254585

SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma

An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Enrollment

70 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two cancer drugs — SYS6010 and enlonstobart — in people with head and neck squamous cell carcinoma (a type of cancer in the mouth, throat, or voice box) that has come back or spread to other parts of the body. **You may be eligible if...** - You are 18 to 75 years old - You have been confirmed by biopsy to have recurrent or metastatic head and neck squamous cell carcinoma - You are not a candidate for surgery or standard chemoradiotherapy to cure the cancer - You meet certain performance and organ function requirements **You may NOT be eligible if...** - Your cancer has not been histologically confirmed - You have serious heart, liver, or kidney problems that prevent treatment - You have active autoimmune disease or are on immunosuppressive therapy - You have uncontrolled infections 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

DRUGSYS6010 injection

SYS6010will be administrated on a 14-day cycle

DRUGEnlonstobart injection

Enlonstobart is a recombinant human anti-PD-1 monoclonal antibody


Locations(1)

Shanghai East Hospital Affiliated To Tongji University

Shanghai, Shanghai Municipality, China

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NCT07254585


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