This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).
Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).
Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.
No prior systemic anti-tumor therapy. For patients who received neoadjuvant/adjuvant therapy or radical concurrent chemoradiotherapy, the interval from the last dose of chemotherapy to disease recurrence or progression must be > 6 months to be eligible for screening.
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Prior treatment with any of the following: anti-PD-1 or anti-PD-L1 antibody therapy; ADC therapy targeting EGFR and/or HER3, or ADC therapy with a topoisomerase I inhibitor as the toxic payload;
Subjects at high risk of bleeding or esophageal fistula, e.g., lesions with large ulcers or direct invasion of vital adjacent organs such as the aorta or trachea;
Subjects with a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose;
Presence of active central nervous system (CNS) metastases;
Sequential
JS212
DrugJS212 will be administered every 3 weeks
JS001
DrugJS001 will be administered every 3 weeks
5-FU
Drug5-FU will be administered on d1and d8 every 3 weeks
dose-limiting toxicity （DLT）
Abnormal changes in laboratory and other tests with clinical significance
adverse event（AE）
Abnormal changes in laboratory and other tests with clinical significance
RP3D
Recommended dose for phase III trial
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Progression free survival(PFS)
The time from first dose to Disease progression or death
overall survival (OS)
The time from first dose to death from any cause
immunogenicity
Incidence of Anti-Drug Antibody (ADA)
Biomarker
exploratory analysis of the correlation between potential biomarkers (which may include PD-L1, EGFR, HER3, etc.) and clinical efficacy of JS212 combination therapy.
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