RecruitingPhase 1Phase 2NCT07327229

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

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

Sponsor

Antengene Biologics Limited

Enrollment

132 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ATG-022, a drug called CAPOX, and others for people with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study is currently recruiting participants at 30 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATG-022

1.8mg/kg Q3W, every 21 days as one cycle

DRUGpembrolizumab/KEYTRUDA®

20mg Q3W, every 21 days as one cycle

DRUGCAPOX

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.

Locations(30)

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Fujian Provincial Cnacer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial Cnacer Hospital

Lanzhou, Gansu, China

Cancer Institute&Hospital Chinese Academy of Medical Sciences

Langfang, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Anyang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan Medical Hospital

Xinxiang, Henan, China

Henan Cnacer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhenghzou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Tongji Medical College of HUST

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Jinan Central Hospital

Jinan, Shandong, China

Shandong Cancer Hospital &Institue

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Tongren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi provincial cancer hospital

Taiyuan, Shanxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The First Affiliated Hospital of XI'AN Jiaotong University

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical Universuty Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xiamen University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07327229

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