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NOT YET RECRUITING
NCT07327229
PHASE1/PHASE2

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

Sponsor: Antengene Biologics Limited

View on ClinicalTrials.gov

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

Official title: 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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-03-01

Completion Date

2029-04-30

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

ATG-022

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

DRUG

pembrolizumab/KEYTRUDA®

20mg Q3W, every 21 days as one cycle

DRUG

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.

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