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

NCT ID: NCT07251062

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 737 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2030-12-30

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.

Detailed Description

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.

Phase II (safety lead-in stage): the safety lead-in stage employs a 3+3 design. It aims to evaluate the safety and tolerability of combination therapy-comprising capecitabine/5-FU administered at a descending dose level starting from DL0 alongside fixed doses of SYS6010 and SG001-in previously untreated patients with unresectable locally advanced or metastatic ESCC. The primary objectives are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).

Phase II (dose expansion stage): Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety lead-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.

Phase II (randomized treatment stage): Upon determination of the RP2D based on prior data, a randomized controlled study will be conducted in a first-line advanced/metastatic esophageal squamous cell carcinoma (ESCC) patient population. Patients will be randomly assigned to three arms: Arm 1: SYS6010+SG001+ capecitabine/5-FU; arm2: investigator's choice of SOC; arm3: SYS6010+SG001.

Phase III is a randomized, controlled, open-label, multicenter study designed to evaluate the efficacy of SYS6010+SG001+capecitabine/5-FU versus investigator's choice of treatment as first-line therapy for advanced/metastatic esophageal squamous cell carcinoma. The Phase III trial design will be finalized based on Phase II results. The preliminary plan is to randomized patients in a 1:1 ratio to either the investigational arm or the control arm. Investigational arm: SYS6010+SG001+capecitabine/5-FU; control arm: investigator's choice of SOC.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Investigator's choice of SOC

Intervention Type: DRUG

1. Camrelizumab + Cisplatin + Paclitaxel

2. Tislelizumab + Cisplatin + Paclitaxel

3. Tislelizumab + Cisplatin + 5-FU/Capecitabine

Phase II(randomized controlled stage): SYS6010+SG001

Group Type: EXPERIMENTAL

SYS6010+SG001

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Phase III: physician's choice of SOC

Group Type: ACTIVE_COMPARATOR

Investigator's choice of SOC

Intervention Type: DRUG

1. Camrelizumab + Cisplatin + Paclitaxel

2. Tislelizumab + Cisplatin + Paclitaxel

3. Tislelizumab + Cisplatin + 5-FU/Capecitabine

Interventions

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.

Intervention Type: DRUG

Investigator's choice of SOC

1. Camrelizumab + Cisplatin + Paclitaxel

2. Tislelizumab + Cisplatin + Paclitaxel

3. Tislelizumab + Cisplatin + 5-FU/Capecitabine

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

SG001: Enlonstobart

Eligibility Criteria

Inclusion Criteria

1. Be able to understand and voluntarily sign the written ICF;

2. Age 18-75 (inclusive) years, male or female;

3. 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;

4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;

5. Life expectancy ≥ 3 months;

Exclusion Criteria

1. Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);

2. 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)

3. 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;

4. With dihydropyrimidine dehydrogenase (DPD) deficiency.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Megalith Biopharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

0311-69085587

Other Identifiers

SYS6010-016

Identifier Type: -

Identifier Source: org_study_id