JS107 versus doctor‑chosen therapy for CLDN18.2‑positive advanced stomach or gastroesophageal junction cancer after first‑line treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open‑label Phase 3 trial that will enroll about 560 patients with CLDN18.2‑positive, HER2‑negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who progressed after at least one prior systemic therapy. Participants are randomized 1:1 to receive JS107 or investigator‑selected chemotherapy (examples include irinotecan, paclitaxel, or docetaxel). CLDN18.2 positivity must be confirmed by central immunohistochemistry on available tumor tissue before randomization, and key eligibility includes ECOG 0–1 and at least one measurable lesion per RECIST v1.1. The co‑primary endpoints are blinded independent central review (BICR) progression‑free survival and overall survival, with safety monitored throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital of Shantou University Medical College
  Shantou, Guangdong, China Recruiting
• Zhoukou Central Hospital
  Zhoukou, Henan, China Recruiting
• AnHui Provincial Cancer Hospital
  Hefei, Anhui, China Not yet recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Yongdong Zhang
• Email: yongdong_zhang@junshipharma.com
• Phone: 18042483763

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.