NCT07484724招募中2 期
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2026年4月13日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- dose-limiting toxicity （DLT）
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected survival ≥ 12 weeks
排除标准
- •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;
- •Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;
- •Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/exclusion criteria;
- •Severe cardiovascular or cerebrovascular disease;
- •Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；
研究组 & 干预措施
Cohort 2:JS212+JS001+5-FU
Experimental
干预措施: JS001 (Drug)
Cohort 1:JS212+JS001
Experimental
干预措施: JS212 (Drug)
Cohort 2:JS212+JS001+5-FU
Experimental
干预措施: JS212 (Drug)
Cohort 2:JS212+JS001+5-FU
Experimental
干预措施: 5-FU (Drug)
Cohort 1:JS212+JS001
Experimental
干预措施: JS001 (Drug)
结局指标
主要结局
dose-limiting toxicity （DLT）
时间窗: up to 4 years
Abnormal changes in laboratory and other tests with clinical significance
adverse event（AE）
时间窗: up to 4 years
Abnormal changes in laboratory and other tests with clinical significance
RP3D
时间窗: up to 4 years
Recommended dose for phase III trial
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
时间窗: up to 4 years
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
次要结局
- Progression free survival(PFS)(up to 2years)
- overall survival (OS)(up to 4 years)
- immunogenicity(up to 2years)
研究者
研究点 (1)
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