Not Yet RecruitingPhase 2/3

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

737 participantsStarted 2025-12-30

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 28 days

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

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

PhaseII(safety leadrun-in stage): MTD;

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

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

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

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

Timeframe: 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

Timeframe: 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;

Timeframe: Through study completion, up to approximately 5 year.

Trial details

NCT IDNCT07251062

SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-30

Contact for this trial

Clinical Trials Information Group officer

0311-69085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 28 days

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

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

PhaseII(safety leadrun-in stage): MTD;

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

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

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

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

Timeframe: 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

Timeframe: 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;

Timeframe: Through study completion, up to approximately 5 year.