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Clinical Trials in China / NCT07327229
Recruiting Phase 1/2

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

NCT07327229 · tracked via the Priya Life Science China tracker
Sponsor
Antengene Biologics Limited
Phase
Phase 1/2
Started
2026-02-27
Last updated
2026-07-29

Condition(s) studied

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

ATG-022pembrolizumab/KEYTRUDA®CAPOX

ATG-022: 1.8mg/kg Q3W, every 21 days as one cycle

pembrolizumab/KEYTRUDA®: 20mg Q3W, every 21 days as one cycle

CAPOX: Standard Dose level for CAPOX: Capecitabine 1000 mg/m2 PO BID on Day 1-14, Oxaliplatin 130 mg/m2 IV on Day 1, Cycled every 21 days (3 weeks) for 8 cycles.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged ≥18 years as of the date of consent. 3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression. 4. 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. 5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators. 6. Estimated life expectancy of a minimum of 12 weeks. Exclusion Criteria: 1. 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. 2. Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE. 3. 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. 4. 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. 5. 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 6. Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 7. 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.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Beijing Cancer hospital Beijing Beijing Municipality Recruiting
Fujian Provincial Cnacer Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Gansu Provincial Cnacer Hospital Lanzhou Gansu Not Yet Recruiting
Cancer Institute&Hospital Chinese Academy of Medical Sciences Langfang Hebei Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
Anyang Tumor Hospital Anyang Henan Recruiting
The First Affiliated Hospital of Henan Medical Hospital Xinxiang Henan Recruiting
Henan Cnacer Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhenghzou University Zhengzhou Henan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Medical College of HUST Wuhan Hubei Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Xuzhou Central Hospital Xuzhou Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
General Hospital of Ningxia Medical University Yinchuan Ningxia Recruiting
Jinan Central Hospital Jinan Shandong Recruiting
Shandong Cancer Hospital &Institue Jinan Shandong Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
Tongren Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Recruiting
Shanxi provincial cancer hospital Taiyuan Shanxi Recruiting
The First Hospital of Shanxi Medical University Taiyuan Shanxi Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University Xi’an Shanxi Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Tianjin Medical Universuty Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
The First Affiliated Hospital of Xiamen University Wenzhou Zhejiang Recruiting

More Antengene Biologics Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327229 on ClinicalTrials.gov ↗ ← All trials in China