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NOT YET RECRUITING
NCT07251062
PHASE2/PHASE3

A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter phase 2/3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU/Capecitabine as first-line treatment, in patients with advanced/metastatic esophageal squamous cell carcinoma.

Official title: A Phase II/III Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU/Capecitabine in Subjects With First-Line Advanced/Metastatic Esophageal Squamous Cell Carcinoma.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

737

Start Date

2025-12-30

Completion Date

2030-12-30

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

DRUG

SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)

SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker. SG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody. Capecitabine: Capecitabine is for oral administration. 5-FU: Administration at the conventional dosage.

DRUG

Investigator's choice of SOC

1. Camrelizumab + Cisplatin + Paclitaxel 2. Tislelizumab + Cisplatin + Paclitaxel 3. Tislelizumab + Cisplatin + 5-FU/Capecitabine

DRUG

SYS6010+SG001

SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker. SG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody.