New hope for stomach cancer: experimental drug JS107 enters final trial phase
NCT ID NCT07284134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial is testing an experimental drug called JS107 against standard treatments for people with advanced stomach or gastroesophageal junction cancer that has gotten worse after at least one prior therapy. The study will enroll about 560 participants who have a specific marker (CLDN18.2) on their cancer cells. The goal is to see if JS107 can help people live longer or delay cancer growth compared to usual care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JS107 (an experimental drug targeting CLDN18.2)
- What this could lead to
- If successful, JS107 could offer a new treatment option for people with advanced gastric cancer that has not responded to prior therapy.
- What could go wrong
- This is an early-stage Phase 3 trial, so results are not guaranteed. The drug may not improve survival or could cause side effects. The study is still recruiting, so outcomes are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 560 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance. 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: 1. Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody). 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
68 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital Of Jiangnan University
NOT_YET_RECRUITINGWuxi, Jiangsu, 214122, China
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Affiliated Hospital of North China University of Technology
NOT_YET_RECRUITINGTangshan, Hebei, 063000, China
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AnHui Provincial Cancer Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230031, China
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Anyang Tumor Hospital
NOT_YET_RECRUITINGAnyang, Henan, 455000, China
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Baotou Tumor Hospital
NOT_YET_RECRUITINGBaotou, Inner Mongolia, 014030, China
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Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100050, China
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Binzhou Medical University Hospital
NOT_YET_RECRUITINGBinzhou, Shandong, 256603, China
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Cancer Hospital Affiliated to Guangxi Medical University
NOT_YET_RECRUITINGNanning, Guangxi, 530000, China
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Cancer Hospital Chinese Academy of Medical Sciences Langfang Campus
NOT_YET_RECRUITINGLangfang, Hebei, 065001, China
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Cancer Hospital of Shantou University Medical College
RECRUITINGShantou, Guangdong, 515041, China
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Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350014, China
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First hospital of Shanxi medical university
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030001, China
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Gansu Provincial Cancer Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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Gansu wuwei tumor hospital
NOT_YET_RECRUITINGWuwei, Gansu, 733000, China
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General Hospital of Ningxia Medical university
NOT_YET_RECRUITINGYinchuan, Ningxia, 750004, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450008, China
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Hubei Cancer Hospital
NOT_YET_RECRUITINGWuhan, Hubei, 430079, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410013, China
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Jiangsu Province Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210029, China
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Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
NOT_YET_RECRUITINGNanchang, Jiangxi, 330029, China
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Liaoning Cancer Hospital&Institute
NOT_YET_RECRUITINGShenyang, Liaoning, 110042, China
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Linfen central hospital
NOT_YET_RECRUITINGLinfen, Shanxi, 041000, China
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Linyi Cancer Hospital
NOT_YET_RECRUITINGLinyi, Shandong, 276000, China
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Linyi People's Hospital
NOT_YET_RECRUITINGLinyi, Shandong, 276034, China
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Meizhou People's Hospital（Huangtang Hospital）
NOT_YET_RECRUITINGMeizhou, Guangdong, 514031, China
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Nanfang hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510515, China
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Nanyang First People's Hospital National Third Class A Hospltal
NOT_YET_RECRUITINGNanyang, Henan, 473010, China
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Northern Jiangsu People's Hospital
NOT_YET_RECRUITINGYangzhou, Jiangsu, 225001, China
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Peking University First Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100034, China
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People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITINGNanning, Guangxi, 530000, China
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Puyang People's Hospital
NOT_YET_RECRUITINGPuyang, Henan, 457100, China
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Sanmenxia Central Hospital
NOT_YET_RECRUITINGSanmenxia, Henan, 472099, China
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Shandong First Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITINGJinan, Shandong, 250117, China
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Shandong Provincial Hospital
NOT_YET_RECRUITINGJi'nan, Shandong, 250021, China
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Shanghai Gobroad Cancer Hospital China Pharmaceutical University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200123, China
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030032, China
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Shanxi cancer hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030013, China
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Shengjing Hospital 0f China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110004, China
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Suining Central Hospital
NOT_YET_RECRUITINGSuining, Sichuan, 629000, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510000, China
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The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, 266075, China
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The First Affiliated Hospital of Henan University of Science & Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471003, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330209, China
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The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325000, China
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The First Affiliated Hospital of Xi'an jiao tong University
NOT_YET_RECRUITINGXi’an, Shanxi, 710061, China
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The First Affiliated Hospital of Zhengzhouuniversity
NOT_YET_RECRUITINGZhengzhou, Henan, 450052, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310003, China
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The First Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, Gansu, 730000, China
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The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, 050011, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310009, China
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The Third Bethune Hospital Of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130033, China
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The Third People's Hospital of Datong
NOT_YET_RECRUITINGDatong, Shanxi, 037046, China
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The second people's hospital of Yibin
NOT_YET_RECRUITINGYibin, Sichuan, 644002, China
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The sixth affiliated hospital sun yat-sen university
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510655, China
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Tongji Hospital, Tongji Medical College, Huazhong University
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
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Union Hospital Affiliated to Fujian Medical University
NOT_YET_RECRUITINGFuzhou, Fujian, 365110, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430040, China
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Weifang People's Hospital
NOT_YET_RECRUITINGWeifang, Shandong, 261000, China
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West China Hospital, Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, 610041, China
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Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, 410008, China
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Xiangyang Cancer Hospital
NOT_YET_RECRUITINGXiangyang, Hubei, 441199, China
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Xinjiang Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 830000, China
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Xuzhou Central Hospital
NOT_YET_RECRUITINGXuzhou, Jiangsu, 221111, China
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Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, Hubei, 443003, China
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Yunnan Cancer Hospital
NOT_YET_RECRUITINGKunming, Yunnan, 650118, China
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Zhejiang Provincial People'S Hospital People'S Hospital of Hangzhou Medicalcollege
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310014, China
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Zhoukou Central Hospital
RECRUITINGZhoukou, Henan, 466099, China
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