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

Browse trials for

• Esophageal Squamous Cell Carcinoma 645

Esophageal Squamous Cell Carcinoma

645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.

This study's planned enrollment of 737 is above the median of 65 across 539 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd. is the lead sponsor of 34 studies on the registry; 33 are open to participants now.

Study arms

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

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

• Experimental
  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.

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

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

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

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

  Drug: Investigator's choice of SOC

• Experimental
  Phase II(randomized controlled stage): SYS6010+SG001

  Drug: SYS6010+SG001

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

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

• Active comparator
  Phase III: physician's choice of SOC

  Drug: Investigator's choice of SOC

Interventions

• DrugSYS6010+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.

  Also known as: SG001: Enlonstobart

• DrugInvestigator's choice of SOC

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

• DrugSYS6010+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.

Primary outcomes

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

   Dose-limiting toxicity

   Time frame: 28 days

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

   The incidence and severity of Adverse events

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

3. PhaseII(safety leadrun-in stage): MTD;

   Maximum tolerated dose

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

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

   Recommended Phase II dose

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

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

   Objective response rate

   Time frame: 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.

6. PhaseIII: PFS-ICR

   PFS assessed by independent review committee

   Time frame: 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

7. PhaseIII: OS;

   Overall survival

   Time frame: Through study completion, up to approximately 5 year.

Secondary outcomes

1. Phase II: DOR per RECIST 1.1;

   Duration of response.

   Time frame: 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

2. Phase II: DCR per RECIST 1.1;

   Disease of controll

   Time frame: 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

3. Phase II:PFS per RECIST 1.1

   Progression free survival

   Time frame: 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

4. Phase II:OS

   Overall survival

   Time frame: Through study completion, up to approximately 5 year

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

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

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

6. Phase II: plasma concentration of SG001 following single and multiple doses of SG001;

   Plasma concentration of SG001 following single and multiple doses of SG001

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

7. Phase II: EGFR protein expression and PD-L1 protein expression;

   EGFR protein expression and PD-L1 protein expression;

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

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.

   The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010.

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

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;

   The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001.

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

10. Phase III: DOR-IRC per RECIST 1.1

    Duration of response assessed by independent review committee

    Time frame: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 weeks thereafter, until the end of the study

11. Phase III: DCR-IRC per RECIST 1.1;

    Disease of controll assessed by independent review committee.

    Time frame: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12

12. Phase III:PFS per RECIST 1.1;

    Progression free survival

    Time frame: 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.

13. Phase III:ORR-IRC;

    Objective response rate assessed by independent review committee

    Time frame: 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.

14. Phase III: AE;

    Incidence and severity of adverse events

    Time frame: From first dose of treatment to 90 days after the last dose of treatment.

15. Phase III: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010;

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

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

16. Phase III: plasma concentration of SG001 following single and multiple doses of SG001

    Plasma concentration of SG001 following single and multiple doses of SG001

    Time frame: 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.

17. Phase III: EGFR protein expression and PD-L1 protein expression

    EGFR protein expression and PD-L1 protein expression

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

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 .

    The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010.

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

19. The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001

    The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001

    Time frame: From first dose of treatment to 30 days after the last dose of treatment