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

ConditionEsophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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

    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.

  • Investigator's choice of SOC

    Drug

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

  • SYS6010+SG001

    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.

Treatment groups

737 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU )Experimental treatment 1 intervention
Group B: Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU)Experimental treatment 1 intervention
Group C: Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)Experimental treatment 1 intervention
Group D: PhaseII(randomized treatment stage): physician's choice of SOCActive comparator 1 intervention
Group E: Phase II(randomized controlled stage): SYS6010+SG001Experimental treatment 1 intervention
Group F: Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)Active comparator 1 intervention
Group G: Phase III: physician's choice of SOCActive comparator 1 intervention

Trial outcomes

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: