Actively Recruiting
JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-01-22
560
Participants Needed
68
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and have signed informed consent
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 3 months
- Confirmed HER2-negative gastric or gastroesophageal junction adenocarcinoma by histology or cytology
- Have received at least one prior systemic treatment including fluorouracil and platinum and experienced disease progression
- Availability of fresh or archival tumor tissue confirmed CLDN18.2 positive by immunohistochemistry before randomization
- At least one measurable lesion according to RECIST v1.1 criteria
- Any side effects or complications from previous treatments resolved to Grade 0 or 1, or stable as judged by investigators
You will not qualify if you...
- Prior treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody)
- Previous treatment with an antibody-drug conjugate loaded with a tubulin inhibitor
- Use of strong CYP3A inhibitors or inducers within 2 weeks or 5 half-lives before randomization
- Chemotherapy, immunotherapy, other anti-tumor therapies, or participation in other clinical trials within 3 weeks before randomization
- Use of oral fluorouracil, small molecule targeted drugs, or traditional Chinese medicine for gastric cancer within 2 weeks before randomization
- Major surgery requiring general anesthesia and hospitalization longer than 24 hours or other clinical trial drug treatment within 4 weeks before randomization
- Radiotherapy within 2 weeks before randomization
- Brain metastases (unless treated and stable with no symptoms for at least 4 weeks), meninges metastases, or spinal cord compression
- Tumor invading critical surrounding structures with high risk of rupture, hemorrhage, airway fistula, or bone metastases with high risk of paraplegia
- Thromboembolic events within 3 months before randomization, except non-pulmonary thromboembolism stably treated for at least 14 days
- History of other malignant tumors within 5 years before randomization, except those cured after treatment
- Active autoimmune diseases requiring systemic treatment within 2 years before randomization
- Known severe allergy to any component of the investigational drug formula
AI-Screening
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Trial Site Locations
Total: 68 locations
1
AnHui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
4
Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
5
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China, 365110
Not Yet Recruiting
6
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
7
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
8
Gansu wuwei tumor hospital
Wuwei, Gansu, China, 733000
Not Yet Recruiting
9
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
10
Nanfang hospital
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
11
The sixth affiliated hospital sun yat-sen university
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
12
Meizhou People's Hospital（Huangtang Hospital）
Meizhou, Guangdong, China, 514031
Not Yet Recruiting
13
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
Actively Recruiting
14
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
15
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530000
Not Yet Recruiting
16
Cancer Hospital Chinese Academy of Medical Sciences Langfang Campus
Langfang, Hebei, China, 065001
Not Yet Recruiting
17
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Not Yet Recruiting
18
Affiliated Hospital of North China University of Technology
Tangshan, Hebei, China, 063000
Not Yet Recruiting
19
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
20
Anyang Tumor Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
21
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471003
Not Yet Recruiting
22
Nanyang First People's Hospital National Third Class A Hospltal
Nanyang, Henan, China, 473010
Not Yet Recruiting
23
Puyang People's Hospital
Puyang, Henan, China, 457100
Not Yet Recruiting
24
Sanmenxia Central Hospital
Sanmenxia, Henan, China, 472099
Not Yet Recruiting
25
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
26
The First Affiliated Hospital of Zhengzhouuniversity
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
27
Zhoukou Central Hospital
Zhoukou, Henan, China, 466099
Actively Recruiting
28
Tongji Hospital, Tongji Medical College, Huazhong University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
29
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430040
Not Yet Recruiting
30
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
31
Xiangyang Cancer Hospital
Xiangyang, Hubei, China, 441199
Not Yet Recruiting
32
Yichang Central People's Hospital
Yichang, Hubei, China, 443003
Not Yet Recruiting
33
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
34
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
35
Baotou Tumor Hospital
Baotou, Inner Mongolia, China, 014030
Not Yet Recruiting
36
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
37
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu, China, 214122
Not Yet Recruiting
38
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221111
Not Yet Recruiting
39
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Not Yet Recruiting
40
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
41
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330209
Not Yet Recruiting
42
The Third Bethune Hospital Of Jilin University
Changchun, Jilin, China, 130033
Not Yet Recruiting
43
Shengjing Hospital 0f China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
44
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
45
General Hospital of Ningxia Medical university
Yinchuan, Ningxia, China, 750004
Not Yet Recruiting
46
Binzhou Medical University Hospital
Binzhou, Shandong, China, 256603
Not Yet Recruiting
47
Shandong Provincial Hospital
Ji'nan, Shandong, China, 250021
Not Yet Recruiting
48
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
49
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
50
Linyi People's Hospital
Linyi, Shandong, China, 276034
Not Yet Recruiting
51
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266075
Not Yet Recruiting
52
Weifang People's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
53
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China, 200123
Not Yet Recruiting
54
The Third People's Hospital of Datong
Datong, Shanxi, China, 037046
Not Yet Recruiting
55
Linfen central hospital
Linfen, Shanxi, China, 041000
Not Yet Recruiting
56
First hospital of Shanxi medical university
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
57
Shanxi cancer hospital
Taiyuan, Shanxi, China, 030013
Not Yet Recruiting
58
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
59
The First Affiliated Hospital of Xi'an jiao tong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
60
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
61
Suining Central Hospital
Suining, Sichuan, China, 629000
Not Yet Recruiting
62
The second people's hospital of Yibin
Yibin, Sichuan, China, 644002
Not Yet Recruiting
63
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
64
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
65
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
66
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
67
Zhejiang Provincial People'S Hospital People'S Hospital of Hangzhou Medicalcollege
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
68
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
Y
Yongdong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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