A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

In brief

This is A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Key facts

Study ID

NCT07327229

Run by

Antengene Biologics Limited

People needed

132

Starts

2026-02-27

Expected to finish

2029-04-30

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• Aged ≥18 years as of the date of consent.
• Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.
• Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria.
• At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators.
• Estimated life expectancy of a minimum of 12 weeks.

You may not qualify if…

• Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.
• Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.
• Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator.
• Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
• Prior radiotherapy within 4 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. Two weeks or fewer of palliative radiotherapy for non- central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention
• Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures≤7 days. No waiting is required following implantable port and catheter placement.

Where it is running

• The First Affiliated Hospital of Xiamen University — Wenzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Beijing Cancer hospital — Beijing, Beijing Municipality, China (enrolling)
• Fujian Provincial Cnacer Hospital — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
• The First Affiliated Hospital of XI'AN Jiaotong University — Xi’an, Shanxi, China (enrolling)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)
• Tianjin Medical Universuty Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Anhui Provincial Hospital — Hefei, Anhui, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Anyang Tumor Hospital — Anyang, Henan, China (enrolling)
• The First Affiliated Hospital of Henan Medical Hospital — Xinxiang, Henan, China (enrolling)
• The First Affiliated Hospital of Zhenghzou University — Zhengzhou, Henan, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Tongji Medical College of HUST — Wuhan, Hubei, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (enrolling)
• Jinan Central Hospital — Jinan, Shandong, China (enrolling)
• Shandong Cancer Hospital &Institue — Jinan, Shandong, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• Tongren Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• Shanxi provincial cancer hospital — Taiyuan, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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