> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sys6010-enlonstobart-and-chemotherapy-for-first-48697d69-c589-4a28-b6e1-e1b1c0b9c4ef > Record changed: 2026-11-04 # A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma. NCT07251062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) Participants 737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) Lead sponsor CSPC Megalith Biopharmaceutical Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) Start date 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Short title** A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Dates **Completion date** 2030-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **First posted** 2025-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Registry last updated** 2025-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Primary completion date** 2029-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Start date** 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Size and sites **Participants** 737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Planned participants** 737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Lead sponsor** CSPC Megalith Biopharmaceutical Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Identifiers **Registry ID** NCT07251062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **ClinicalTrials.gov ID** NCT07251062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Outcomes ### Primary outcomes 1. PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity Timeframe: 28 days Dose-limiting toxicity 2. PhaseII(safety run-inlead-in stage): AE Timeframe: From the signing of the informed consent form until 90 days after the last dose. The incidence and severity of Adverse events 3. PhaseII(safety leadrun-in stage): MTD; Timeframe: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months. Maximum tolerated dose 4. PhaseII(safety run-inlead-in stage): RP2D Timeframe: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months. Recommended Phase II dose 5. 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. Objective response rate 6. 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 PFS assessed by independent review committee 7. PhaseIII: OS; Timeframe: Through study completion, up to approximately 5 year. Overall survival ### Secondary outcomes 1. Phase II: DOR per RECIST 1.1; 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 Duration of response. 2. Phase II: DCR per RECIST 1.1; 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 Disease of controll 3. Phase II:PFS per RECIST 1.1 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 Progression free survival 4. Phase II:OS Timeframe: Through study completion, up to approximately 5 year Overall survival 5. Phase II: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010 Timeframe: From first dose of treatment to 30 days after the last dose of treatment. Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010 6. Phase II: plasma concentration of SG001 following single and multiple doses of SG001; Timeframe: From first dose of treatment to 30 days after the last dose of treatment. Plasma concentration of SG001 following single and multiple doses of SG001 7. Phase II: EGFR protein expression and PD-L1 protein expression; Timeframe: From first dose of treatment to 30 days after the last dose of treatment. EGFR protein expression and PD-L1 protein expression; 8. Phase II: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010. Timeframe: From first dose of treatment to 30 days after the last dose of treatment. The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010. 9. Phase II: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001; Timeframe: From first dose of treatment to 30 days after the last dose of treatment. The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001. 10. Phase III: DOR-IRC per RECIST 1.1 Timeframe: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 weeks thereafter, until the end of the study Duration of response assessed by independent review committee 11. Phase III: DCR-IRC per RECIST 1.1; Timeframe: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 Disease of controll assessed by independent review committee. 12. Phase III:PFS per RECIST 1.1; 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. Progression free survival 13. Phase III:ORR-IRC; 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. Objective response rate assessed by independent review committee 14. Phase III: AE; Timeframe: From first dose of treatment to 90 days after the last dose of treatment. Incidence and severity of adverse events 15. Phase III: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010; Timeframe: From first dose of treatment to 30 days after the last dose of treatment. Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010 16. Phase III: plasma concentration of SG001 following single and multiple doses of SG001 Timeframe: From first dose of treatment to 30 days after the last dose of treatment.From first dose of treatment to 30 days after the last dose of treatment. Plasma concentration of SG001 following single and multiple doses of SG001 17. Phase III: EGFR protein expression and PD-L1 protein expression Timeframe: From first dose of treatment to 30 days after the last dose of treatment. EGFR protein expression and PD-L1 protein expression 18. Phase III: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010 . Timeframe: From first dose of treatment to 30 days after the last dose of treatment. The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010. 19. The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001 Timeframe: From first dose of treatment to 30 days after the last dose of treatment The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07251062) ## Related records ### Drugs (2) - [Enlonstobart](https://trialight.com/data/asset/enlonstobart-6441d39e-4fec-4bb7-ac06-e1f1ecd9f682.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) ### Lead sponsors (1) - [CSPC Megalith Biopharmaceutical Co.,Ltd.](https://trialight.com/data/company/cspc-megalith-biopharmaceutical-co-ltd-3e23baf5-2c63-4924-bd71-93a2333b9a1f.md) ### Conditions (1) - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Primary condition ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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