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

NCT07251062 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SYS6010-016
• Study Type: interventional
• Target: 737
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (7)

• PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity

  Dose-limiting toxicity

  28 days

• PhaseII(safety run-inlead-in stage): AE

  The incidence and severity of Adverse events

  From the signing of the informed consent form until 90 days after the last dose.

• PhaseII(safety leadrun-in stage): MTD;

  Maximum tolerated dose

  After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.

• PhaseII(safety run-inlead-in stage): RP2D

  Recommended Phase II dose

  After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.

• PhaseII(Randomized treatment stage): ORR per RECIST v1.1

  Objective response rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

• PhaseIII: PFS-ICR

  PFS assessed by independent review committee

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• PhaseIII: OS;

  Overall survival

  Through study completion, up to approximately 5 year.

Secondary Outcomes (19)

• Phase II: DOR per RECIST 1.1;

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Phase II: DCR per RECIST 1.1;

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Phase II:PFS per RECIST 1.1

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Phase II:OS

  Through study completion, up to approximately 5 year

• Phase II: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010

  From first dose of treatment to 30 days after the last dose of treatment.

Study Arms (7)

Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU )

EXPERIMENTAL

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

Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU)

EXPERIMENTAL

Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety run-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.

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

Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)

EXPERIMENTAL

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

PhaseII(randomized treatment stage): physician's choice of SOC

ACTIVE COMPARATOR

Drug: Investigator's choice of SOC

Phase II(randomized controlled stage): SYS6010+SG001

EXPERIMENTAL

Drug: SYS6010+SG001

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

ACTIVE COMPARATOR

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

Phase III: physician's choice of SOC

ACTIVE COMPARATOR

Drug: Investigator's choice of SOC

Interventions

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

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.

Also known as: SG001: Enlonstobart

Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU ); Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU); Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU); Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)

Investigator's choice of SOC DRUG

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

Phase III: physician's choice of SOC; PhaseII(randomized treatment stage): physician's choice of SOC

SYS6010+SG001 DRUG

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.

Phase II(randomized controlled stage): SYS6010+SG001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and voluntarily sign the written ICF;
• Age 18-75 (inclusive) years, male or female;
• With histologically/cytologically confirmed esophageal squamous cell carcinoma that is either locally advanced unresectable or metastatic, with no prior systemic antitumor therapy administered for the recurrent/metastatic disease setting. Have at least one measurable lesion that meets the RECIST v 1.1 criteria at baseline;
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
• Life expectancy ≥ 3 months;

You may not qualify if:

• Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);
• Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory/co-inhibitory pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 antibodies)
• With a history of ≥Grade 3 allergic reactions to monoclonal antibodies, or with known hypersensitivity or intolerance to SYS6010, SG001, paclitaxel, carboplatin, cisplatin, fluorouracil, or any of their excipients;
• With dihydropyrimidine dehydrogenase (DPD) deficiency.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Capecitabine; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase II/III study. Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 26, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-10