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

NCT07251062
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Phase
Phase 2/Phase 3
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Recruitment status
Not yet recruiting
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Participants
737
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Lead sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
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Start date
2025-12-30
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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.
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Short title
A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.
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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.
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2030-12-30
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First posted
2025-11-26
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Registry last updated
2025-11-26
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Primary completion date
2029-12-30
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Start date
2025-12-30
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Participants
737
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Participant count basis
Estimated
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Planned participants
737
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Protocol amendments
0
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Randomisation ratio
1:1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07251062
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ClinicalTrials.gov ID
NCT07251062
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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;

  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
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)