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JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Summary
This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2. The study population consists of patients with CLDN18.2-positive, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival. Number of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
560
Start Date
2025-12-24
Completion Date
2028-10-17
Last Updated
2026-01-22
Healthy Volunteers
No
Interventions
JS107 for Injection
Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Irinotecan
Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Paclitaxel
Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Docetaxel
Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Locations (68)
AnHui Provincial Cancer Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Gansu wuwei tumor hospital
Wuwei, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang hospital
Guangzhou, Guangdong, China
The sixth affiliated hospital sun yat-sen university
Guangzhou, Guangdong, China
Meizhou People's Hospital（Huangtang Hospital）
Meizhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Cancer Hospital Chinese Academy of Medical Sciences Langfang Campus
Langfang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Hospital of North China University of Technology
Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Nanyang First People's Hospital National Third Class A Hospltal
Nanyang, Henan, China
Puyang People's Hospital
Puyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhouuniversity
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Cancer Hospital
Xiangyang, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Baotou Tumor Hospital
Baotou, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Third Bethune Hospital Of Jilin University
Changchun, Jilin, China
Shengjing Hospital 0f China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical university
Yinchuan, Ningxia, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shandong Provincial Hospital
Ji'nan, Shandong, China
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
The Third People's Hospital of Datong
Datong, Shanxi, China
Linfen central hospital
Linfen, Shanxi, China
First hospital of Shanxi medical university
Taiyuan, Shanxi, China
Shanxi cancer hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an jiao tong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
The second people's hospital of Yibin
Yibin, Sichuan, China
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People'S Hospital People'S Hospital of Hangzhou Medicalcollege
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China