JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
NCT ID: NCT07284134
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
560 participants
INTERVENTIONAL
2025-12-20
2028-10-17
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
JS107: 3mg/kg, intravenous infusion, on Day 1, with a treatment cycle of every 21 days.
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).
Control group
Including 3 treatment regimens: irinotecan, paclitaxel, and docetaxel. investigators will select one regimen based on the patient's previous treatment medications, clinical benefits, and tolerability, and the administration will follow clinical guidelines and/or clinical practices. In addition, before administration, corresponding premedications (including antiemetics, preventive anti-allergy drugs, etc.) can be given with reference to clinical guidelines or drug instructions.
Irinotecan: 150mg/m², intravenous infusion, on days 1 and 15, with a 28-day treatment cycle.
Paclitaxel: 80mg/m², intravenous infusion, on days 1, 8, and 15, with a 28-day treatment cycle.
Docetaxel: 75mg/m², intravenous infusion, on day 1, with a 21-day treatment cycle.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years, male or female.
3. ECOG PS 0 or 1.
4. Expected survival period≥ 3 months.
5. Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology.
6. Patients who have received at least one prior line of systemic treatments and developed PD, and the previous treatment must include fluorouracil and platinum.
7. Fresh or archival tumor tissue (blocks of formalin-fixed, paraffin-embedded \[FFPE\] tissue or unstained FFPE tumor tissue sections) must be available and comfirmed CLDN18.2 positivity by for central laboratory through immunohistochemistry (IHC) before randomization.
8. Having ≥ 1 measurable lesion according to RECIST v1.1 (per investigator assessment).
9. Any AEs and/or complications caused by previous therapies including surgery or radiotherapy have been adequately resolved to Grade 0 or 1 (per NCI-CTCAE v5.0 criteria) or have been stabilized in the judgment of investigators.
Exclusion Criteria
2. Previously treated with an ADC loaded with a tubulin inhibitor.
3. Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer.
4. Use of chemotherapy, immunotherapy or other anti-tumor therapies or participation in other clinical trials within 3 weeks prior to randomization, or use of oral fluorouracil, small molecule targeted drugs or traditional Chinese medicine for gastric cancer within 2 weeks prior to randomization.
5. Major surgery (requiring general anaesthesia and \>24 hours of Hospitalisation) or other clincal trial drug treatment within 4 weeks prior to randomization, or radiotherapy within 2 weeks prior to randomization.
6. Imaging demonstrating brain metastases (except patients who have completed whole brain radiotherapy or local therapy (such as surgery), have discontinued prednisone for at least 4 weeks prior to randomization, and have stable radiologically confirmed tumor lesions and no clinical symptoms of tumor during 4 weeks prior to randomization), metastases to meninges, or spinal cord compression.
7. Tumor invades important surrounding structures (e.g., large blood vessels, trachea, etc.) with high risk of rupture and hemorrhage or airway fistula, or metastases to bone with high risk of paraplegia.
8. Thromboembolic events within 3 months prior to randomization (except patients with non-pulmonary Thromboembolism who do not require treatment or have been stably treated with anticoagulants for 14 days or longer prior to randomization).
9. History of other neoplasm malignant within 5 years prior to randomization, except for neoplasm malignant cured after treatment.
10. Having active autoimmune diseases requiring systemic treatment (i.e., immunologic modulator, corticosteroid, or Immunosuppression) within 2 years prior to randomization; replacement therapy (such as thyroid hormone, Insulin, or physiologic corticosteroid replacement therapy due to adrenal or pituitary insufficiency) is not considered systemic treatment.
11. Known severe allergic reaction to any component in the investigational drug formula.
18 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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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
The First Hospital of 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JS107-006-III-GC
Identifier Type: -
Identifier Source: org_study_id