Esophageal Squamous Cell CarcinomaPhase 2/3NCT07251062
A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.
A Phase 2/3 study testing SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Investigator's choice of SOC and SYS6010+SG001 in people with Esophageal Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Investigator's choice of SOC and SYS6010+SG001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the detailed description
Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.
Phase II (safety lead-in stage): the safety lead-in stage employs a 3+3 design. It aims to evaluate the safety and tolerability of combination therapy-comprising capecitabine/5-FU administered at a descending dose level starting from DL0 alongside fixed doses of SYS6010 and SG001-in previously untreated patients with unresectable locally advanced or metastatic ESCC. The primary objectives are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).
Phase II (dose expansion stage): Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety lead-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.
Phase II (randomized treatment stage): Upon determination of the RP2D based on prior data, a randomized controlled study will be conducted in a first-line advanced/metastatic esophageal squamous cell carcinoma (ESCC) patient population. Patients will be randomly assigned to three arms: Arm 1: SYS6010+SG001+ capecitabine/5-FU; arm2: investigator's choice of SOC; arm3: SYS6010+SG001.
Phase III is a randomized, controlled, open-label, multicenter study designed to evaluate the efficacy of SYS6010+SG001+capecitabine/5-FU versus investigator's choice of treatment as first-line therapy for advanced/metastatic esophageal squamous cell carcinoma. The Phase III trial design will be finalized based on Phase II results. The preliminary plan is to randomized patients in a 1:1 ratio to either the investigational arm or the control arm. Investigational arm: SYS6010+SG001+capecitabine/5-FU; control arm: investigator's choice of SOC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Investigator's choice of SOC, SYS6010+SG001
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)Drug
Also called SG001: Enlonstobart
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 SOCDrug
- Camrelizumab + Cisplatin + Paclitaxel
- Tislelizumab + Cisplatin + Paclitaxel
- Tislelizumab + Cisplatin + 5-FU/Capecitabine
SYS6010+SG001Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU ) | Experimental | Not described Receives: Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU) | Experimental | 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. Receives: Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) | Experimental | Not described Receives: Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| PhaseII(randomized treatment stage): physician's choice of SOC | Active comparator | Not described Receives: Drug: Investigator's choice of SOC |
| Phase II(randomized controlled stage): SYS6010+SG001 | Experimental | Not described Receives: Drug: SYS6010+SG001 |
| Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) | Active comparator | Not described Receives: Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Phase III: physician's choice of SOC | Active comparator | Not described Receives: Drug: Investigator's choice of SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity
Dose-limiting toxicity
Measured: 28 days
PhaseII(safety run-inlead-in stage): AE
The incidence and severity of Adverse events
Measured: From the signing of the informed consent form until 90 days after the last dose.
PhaseII(safety leadrun-in stage): MTD;
Maximum tolerated dose
Measured: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.
PhaseII(safety run-inlead-in stage): RP2D
Recommended Phase II dose
Measured: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.
PhaseII(Randomized treatment stage): ORR per RECIST v1.1
Objective response rate
Measured: 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
PFS assessed by independent review committee
Measured: 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;
Overall survival
Measured: Through study completion, up to approximately 5 year.
Secondary outcomes (19)
Phase II: DOR per RECIST 1.1;
Duration of response.
Measured: 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
Phase II: DCR per RECIST 1.1;
Disease of controll
Measured: 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
Phase II:PFS per RECIST 1.1
Progression free survival
Measured: 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
Phase II:OS
Overall survival
Measured: Through study completion, up to approximately 5 year
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
Measured: From first dose of treatment to 30 days after the last dose of treatment.
Phase II: plasma concentration of SG001 following single and multiple doses of SG001;
Plasma concentration of SG001 following single and multiple doses of SG001
Measured: From first dose of treatment to 30 days after the last dose of treatment.
Phase II: EGFR protein expression and PD-L1 protein expression;
EGFR protein expression and PD-L1 protein expression;
Measured: From first dose of treatment to 30 days after the last dose of treatment.
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.
Measured: From first dose of treatment to 30 days after the last dose of treatment.
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.
Measured: From first dose of treatment to 30 days after the last dose of treatment.
Phase III: DOR-IRC per RECIST 1.1
Duration of response assessed by independent review committee
Measured: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 weeks thereafter, until the end of the study
Phase III: DCR-IRC per RECIST 1.1;
Disease of controll assessed by independent review committee.
Measured: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12
Phase III:PFS per RECIST 1.1;
Progression free survival
Measured: 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.
Phase III:ORR-IRC;
Objective response rate assessed by independent review committee
Measured: 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.
Phase III: AE;
Incidence and severity of adverse events
Measured: From first dose of treatment to 90 days after the last dose of treatment.
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
Measured: From first dose of treatment to 30 days after the last dose of treatment.
Phase III: plasma concentration of SG001 following single and multiple doses of SG001
Plasma concentration of SG001 following single and multiple doses of SG001
Measured: 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.
Phase III: EGFR protein expression and PD-L1 protein expression
EGFR protein expression and PD-L1 protein expression
Measured: From first dose of treatment to 30 days after the last dose of treatment.
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.
Measured: 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
The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001
Measured: From first dose of treatment to 30 days after the last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a Phase II/III study. Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 737 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251062
- Sponsor's protocol ID
- SYS6010-016
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07251062
- Acronym / sponsor ID
- SYS6010-016
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 737 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.
Phase II (safety lead-in stage): the safety lead-in stage employs a 3+3 design. It aims to evaluate the safety and tolerability of combination therapy-comprising capecitabine/5-FU administered at a descending dose level starting from DL0 alongside fixed doses of SYS6010 and SG001-in previously untreated patients with unresectable locally advanced or metastatic ESCC. The primary objectives are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).
Phase II (dose expansion stage): Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety lead-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.
Phase II (randomized treatment stage): Upon determination of the RP2D based on prior data, a randomized controlled study will be conducted in a first-line advanced/metastatic esophageal squamous cell carcinoma (ESCC) patient population. Patients will be randomly assigned to three arms: Arm 1: SYS6010+SG001+ capecitabine/5-FU; arm2: investigator's choice of SOC; arm3: SYS6010+SG001.
Phase III is a randomized, controlled, open-label, multicenter study designed to evaluate the efficacy of SYS6010+SG001+capecitabine/5-FU versus investigator's choice of treatment as first-line therapy for advanced/metastatic esophageal squamous cell carcinoma. The Phase III trial design will be finalized based on Phase II results. The preliminary plan is to randomized patients in a 1:1 ratio to either the investigational arm or the control arm. Investigational arm: SYS6010+SG001+capecitabine/5-FU; control arm: investigator's choice of SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- This is a Phase II/III study. Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU ) | Experimental | Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU) | Experimental | Drug: 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. |
| Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) | Experimental | Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| PhaseII(randomized treatment stage): physician's choice of SOC | Active comparator | Drug: Investigator's choice of SOC |
| Phase II(randomized controlled stage): SYS6010+SG001 | Experimental | Drug: SYS6010+SG001 |
| Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) | Active comparator | Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Phase III: physician's choice of SOC | Active comparator | Drug: Investigator's choice of SOC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)Also: SG001: EnlonstobartSYS6010 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. | Drug | Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU ), Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU), Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU) |
| Investigator's choice of SOC1. Camrelizumab + Cisplatin + Paclitaxel 2. Tislelizumab + Cisplatin + Paclitaxel 3. Tislelizumab + Cisplatin + 5-FU/Capecitabine | Drug | Phase III: physician's choice of SOC, PhaseII(randomized treatment stage): physician's choice of SOC |
| SYS6010+SG001SYS6010 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. | Drug | Phase II(randomized controlled stage): SYS6010+SG001 |
Primary outcome
PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity
Time frame: 28 days
Dose-limiting toxicity
PhaseII(safety run-inlead-in stage): AE
Time frame: From the signing of the informed consent form until 90 days after the last dose.
The incidence and severity of Adverse events
PhaseII(safety leadrun-in stage): MTD;
Time frame: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.
Maximum tolerated dose
PhaseII(safety run-inlead-in stage): RP2D
Time frame: After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.
Recommended Phase II dose
PhaseII(Randomized treatment stage): ORR per RECIST v1.1
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.
Objective response rate
PhaseIII: PFS-ICR
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
PFS assessed by independent review committee
PhaseIII: OS;
Time frame: Through study completion, up to approximately 5 year.
Overall survival
19 secondary outcomes
Phase II: DOR per RECIST 1.1;
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
Phase II: DCR per RECIST 1.1;
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
Phase II:PFS per RECIST 1.1
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
Phase II:OS
Time frame: Through study completion, up to approximately 5 year
Phase II: 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.
Phase II: 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.
Phase II: EGFR protein expression and PD-L1 protein expression;
Time frame: From first dose of treatment to 30 days after the last dose of treatment.
Phase II: 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.
Phase II: 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.
Phase III: DOR-IRC per RECIST 1.1
Time frame: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 weeks thereafter, until the end of the study
Phase III: DCR-IRC per RECIST 1.1;
Time frame: Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12
Phase III:PFS per RECIST 1.1;
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.
Phase III:ORR-IRC;
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.
Phase III: AE;
Time frame: From first dose of treatment to 90 days after the last dose of treatment.
Phase III: 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.
Phase III: 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.
Phase III: EGFR protein expression and PD-L1 protein expression
Time frame: From first dose of treatment to 30 days after the last dose of treatment.
Phase III: 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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Investigator's choice of SOC and SYS6010+SG001 in people with Esophageal Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.