Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3NCT07284134

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.

A Phase 3 study testing JS107 for Injection, Irinotecan and Paclitaxel in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 68 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: JS107 for Injection, Irinotecan and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 560 participants
Where: 68 sitesChina
Study dates: 24 Dec 2025to 17 Oct 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance.
Age ≥ 18 years, male or female.
ECOG PS 0 or 1.
Expected survival period≥ 3 months.
Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology.
Patients who have received at least one prior line of systemic treatments and developed PD, and the previous treatment must include fluorouracil and platinum.

Show all 9Show fewer

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.
Having ≥ 1 measurable lesion according to RECIST v1.1 (per investigator assessment).
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.

Who cannot join

Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody).
Previously treated with an ADC loaded with a tubulin inhibitor.
Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer.
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.
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.
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.

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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.
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).
History of other neoplasm malignant within 5 years prior to randomization, except for neoplasm malignant cured after treatment.
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.
Known severe allergic reaction to any component in the investigational drug formula.

Trial locations and contacts

68 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongdong Zhang contact

18042483763

yongdong_zhang@junshipharma.com

City, postcode or hospital

Sites recruiting now only

68 sites in 1 country

China68 sites, 68 recruiting

Anyang Tumor Hospital
Anyang, Henan, 455000
Jin Xia, Doctor, 15890750990@126.com
Not yet recruiting
Baotou Tumor Hospital
Baotou, Inner Mongolia, 014030
Weidong Guo, Doctor, gwd11152023@163.com
Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shikai Wu, Doctor, skywu4923@sina.com
Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Zhongtao Zhang, Doctor, zhangzht@ccmu.edu.cn
Not yet recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Fangling Ning, Doctor, ningfangling@126.com
Not yet recruiting
The Third Bethune Hospital Of Jilin University
Changchun, Jilin, 130033
Enyong Dai, Doctor, 58748854@qq.com
Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Jie Ge, Doctor, goaljay@qq.com
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Haiyan Yang, Doctor, yanghaiyan@hnca.org.cn
Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Ming Liu, Doctor, mingliu721@aliyun.com
Not yet recruiting
The Third People's Hospital of Datong
Datong, Shanxi, 037046
Chengxu Cui, Doctor, Zhongliuke666@163.com
Not yet recruiting
Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin, Doctor, linrongbo@fjzlhospital.com
Not yet recruiting
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, 365110
Xiaoyan Lin, Doctor, xiaoyanlin@yahoo.com
Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Ruihua Xu, Doctor, xurh@sysucc.org.cn
Ruihua Xu, Doctor
Not yet recruiting
Nanfang hospital
Guangzhou, Guangdong, 510515
Liying Zhao, Doctor, zlyblue11@163.com
Not yet recruiting
The sixth affiliated hospital sun yat-sen university
Guangzhou, Guangdong, 510655
Yanhong Deng, Doctor, 13925106525@163.com
Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jianzhen Shan, Doctor, jianzhenshan@163.com
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Caixia Dong, Doctor, dcx_1982@163.com
Not yet recruiting
Zhejiang Provincial People'S Hospital People'S Hospital of Hangzhou Medicalcollege
Hangzhou, Zhejiang, 310014
Zhiquan Qin, Doctor, qzq66@126.com
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, Doctor, yanqiaozhanggcp@163.com
Not yet recruiting
AnHui Provincial Cancer Hospital
Hefei, Anhui, 230031
Yifu He, Doctor, 834638033@qq.com
Not yet recruiting
Shandong Provincial Hospital
Ji'nan, Shandong, 250021
Lei Cong, Doctor, wdconglei@163.com
Not yet recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Zuoxing Niu, Doctor, nzxsdth@163.com
Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Lin Xie, Doctor, xielinyanghangcp@163.com
Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences Langfang Campus
Langfang, Hebei, 065001
Yongkun Sun, Doctor, hsunyk@126.com
Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoming Hou, Doctor, 1795950416@qq.com
Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Zhihu Li, Doctor, zhihu_li666@163.com
Not yet recruiting
Linfen central hospital
Linfen, Shanxi, 041000
Xuehong Zhao, Doctor, 317059815@qq.com
Not yet recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276000
Zhen Li, Doctor, lizhensdly@126.com
Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 276034
Zhongmin Zhang, Doctor, rtog@163.com
Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471003
Ruinuo Jia, Doctor, power7722@sina.com
Not yet recruiting
Meizhou People's Hospital（Huangtang Hospital）
Meizhou, Guangdong, 514031
Xiaoyang Wang, Doctor, 1002192141@qq.com
Not yet recruiting
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi, 330029
Rongfeng Song, Doctor, rfeng3471@163.com
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
Yong Li, Doctor, liyongcsco@qq.com
Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Tongshan Wang, Doctor, kingtsh@163.com
Not yet recruiting
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530000
Yongqiang Li, Doctor, lyq702702@126.com
Not yet recruiting
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530000
Kehe Chen, Doctor, ckh@163.com
Not yet recruiting
Nanyang First People's Hospital National Third Class A Hospltal
Nanyang, Henan, 473010
Zhen Zhang, Doctor, zhangzhen1771@163.com
Not yet recruiting
Puyang People's Hospital
Puyang, Henan, 457100
Honglin Zhou, Doctor, 28442127@qq.com
Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266075
Libin Sun, Doctor, mycharites@hotmail.com
Not yet recruiting
Sanmenxia Central Hospital
Sanmenxia, Henan, 472099
Xiangqian Zhang, Doctor, 39343883@qq.com
Not yet recruiting
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, 200123
Jun Zhou, Doctor, zhouj2@gobroadhealthcare.com
Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Yi Jiang, Doctor, jiangyi_123@sina.com
Recruiting
Shengjing Hospital 0f China Medical University
Shenyang, Liaoning, 110004
Jing Liu, Doctor, liujing23@vip.163.com
Not yet recruiting
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, 110042
Xi Dong, Doctor, dongqian08@163.com
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Fengbin Zhang, Doctor, zhangfengbin1981@163.com
Not yet recruiting
Suining Central Hospital
Suining, Sichuan, 629000
Li Liu, Doctor, olxll@163.com
Not yet recruiting
First hospital of Shanxi medical university
Taiyuan, Shanxi, 030001
Yusheng Wang, Doctor, wangyusheng1972@163.com
Not yet recruiting
Shanxi cancer hospital
Taiyuan, Shanxi, 030013
Hongxia Lu, Doctor, 53473139@qq.com
Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Yarong Guo, Doctor, gyr5258@126.com
Not yet recruiting
Affiliated Hospital of North China University of Technology
Tangshan, Hebei, 063000
Guogui Sun, Doctor, guogui_sun2021@sina.com
Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830000
Yong Tang, Doctor, ae717ty@163.com
Not yet recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Guohua Yu, Doctor, ghyry@126.com
Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yin Jin, Doctor, wzjinyin@163.com
Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University
Wuhan, Hubei, 430000
Hong Qiu, Doctor, tjqiuhong@163.com
Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430040
Hongli Liu, Doctor, hongli_liu@hust.edu.cn
Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, Doctor, Doctorlxj@163.com
Not yet recruiting
Gansu wuwei tumor hospital
Wuwei, Gansu, 733000
Peng Nie, Doctor, nie.peng2008@163.com
Not yet recruiting
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu, 214122
Zhenyu Xu, Doctor, njzheng@163.com
Not yet recruiting
The First Affiliated Hospital of Xi'an jiao tong University
Xi’an, Shanxi, 710061
Aili Suo, Doctor, ailisuo@mail.xjtu.edu.cn
Not yet recruiting
Xiangyang Cancer Hospital
Xiangyang, Hubei, 441199
Wei Gong, Doctor, 44828977@qq.com
Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221111
Yuan Yuan, Doctor, wwww8866@163.com
Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Xianwen Zhang, Doctor, zxwsbrm@163.com
Not yet recruiting
The second people's hospital of Yibin
Yibin, Sichuan, 644002
Kaijian Lei, Doctor, lkj600@163.com
Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443003
Qiao Huang, Doctor, huangqiao929@hotmail.com
Not yet recruiting
General Hospital of Ningxia Medical university
Yinchuan, Ningxia, 750004
Ping Chen, Doctor, chenping2536@qq.com
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Shujun Yang, Doctor, nkyang@126.com
Not yet recruiting
The First Affiliated Hospital of Zhengzhouuniversity
Zhengzhou, Henan, 450052
Yanru Qin, Doctor, yanruqin@163.com
Not yet recruiting
Zhoukou Central Hospital
Zhoukou, Henan, 466099
Jiye Xu, Doctor, xujiye1998@163.com
Recruiting

Other trials in China

About this study

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).

Read the detailed description

Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology. who have received at one prior line of systemic treatment and developed PD, and the previous treatment must include fluorouracil and platinum; CLDN18.2-positive, HER2-negative.

Conditions: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: JS107 for Injection, Irinotecan, Paclitaxel, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JS107 for InjectionDrug
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).
IrinotecanDrug
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).
PaclitaxelDrug
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).
DocetaxelDrug
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).

Study groups in NCT07284134
Study group	Role	What they receive
Experimental group	Experimental	JS107: 3mg/kg, intravenous infusion, on Day 1, with a treatment cycle of every 21 days. Receives: Drug: JS107 for Injection
Control group	Active comparator	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. Receives: Drug: Irinotecan; Drug: Paclitaxel; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

BICR-PFS
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Measured: up to 2 years
Overall Survival
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.
Measured: up to 5 years

Secondary outcomes (8)

INV-PFS
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-ORR or INV-ORR
ORR evaluated by investigators or BICR (according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-DCR or INV -DCR
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Measured: up to 2 years
BICR-DoR or INV -DoR
DoR (based on the RECIST v1.1 criteria) evaluated by investigators or BICR
Measured: up to 2 years
The incidence rate and severity of AE
The incidence and severity of adverse events (AEs) evaluated according to the NCI-CTC AE v5.0 standard
Measured: up to 2 years
Valley concentration of JS107
Valley concentration of JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years
anti-drug antibodies (ADA) for JS107
Incidence and titer of anti-drug antibodies (ADA) for JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years
Incidence of neutralizing antibodies (NAb) to JS107
Incidence of neutralizing antibodies (NAb) to JS107 (including ADC, total antibody, and toxin)
Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Dec 202517 Oct 2028

First posted16 Dec 2025
Study start24 Dec 2025
Primary completion13 Oct 2027 (estimated)
Study completion17 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 560 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07284134
Sponsor's protocol ID: JS107-006-III-GC
Status last verified: Jan 2026
First submitted: 3 Dec 2025
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
ClinicalTrials.gov ID: NCT07284134
Acronym / sponsor ID: JS107-006-III-GC
Conditions: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 560 participants (estimated)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Study start: 24 Dec 2025 (actual)
Primary completion: 13 Oct 2027 (estimated)
Study completion: 17 Oct 2028 (estimated)
First posted: 16 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: JS107 for InjectionJS107: 3mg/kg, intravenous infusion, on Day 1, with a treatment cycle of every 21 days.
Control group	Active comparator	Drug: Irinotecan, Drug: Paclitaxel, Drug: DocetaxelIncluding 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance.
Age ≥ 18 years, male or female.
ECOG PS 0 or 1.
Expected survival period≥ 3 months.
Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology.

Key exclusion criteria (11 listed)

Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody).
Previously treated with an ADC loaded with a tubulin inhibitor.
Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JS107 for InjectionSubjects 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).	Drug	Experimental group
IrinotecanSubjects 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).	Drug	Control group
PaclitaxelSubjects 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).	Drug	Control group
DocetaxelSubjects 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).	Drug	Control group

Primary outcome

BICR-PFS
Time frame: up to 2 years
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Overall Survival
Time frame: up to 5 years
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.

8 secondary outcomes

INV-PFS
Time frame: up to 2 years
BICR-ORR or INV-ORR
Time frame: up to 2 years
BICR-DCR or INV -DCR
Time frame: up to 2 years
BICR-DoR or INV -DoR
Time frame: up to 2 years
The incidence rate and severity of AE
Time frame: up to 2 years
Valley concentration of JS107
Time frame: up to 2 years
anti-drug antibodies (ADA) for JS107
Time frame: up to 2 years
Incidence of neutralizing antibodies (NAb) to JS107
Time frame: up to 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Individual participant dataSharing planned: No

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Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yongdong Zhang contact

18042483763

yongdong_zhang@junshipharma.com

68 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yongdong Zhang (18042483763, yongdong_zhang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BICR-PFS (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07284134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.