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RECRUITING

NCT07795346

PHASE3

A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor: Antengene Biologics Limited

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, open-label, multicenter Phase III study to evaluate the efficacy and safety of ATG-022 compared with Investigator's Choice in participants with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ATG-022 Compared With Investigator's Choice of Treatment in Subjects With Claudin18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2026-09-17

Completion Date

2029-12-31

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

ATG-022

1.8 mg/kg,D1, Q3W，every 21 days as one cycle

DRUG

Docetaxel or Irinotecan

Docetaxel: 75-100 mg/m², D1, Q3W, every 21 days as one cycle Irinotecan: 125 mg/m², D1, D8, Q3W, every 21 days as one cycle

Inclusion Criteria: 1. Provide signed and dated written informed consent (ICF) before any study-specific procedures, sampling, and analyses. 2. Age ≥ 18 years at the time of consent. 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression. 4. Disease progression after at least second-line and no more than fourth-line systemic therapy. Prior therapy must have included a fluoropyrimidine and a platinum agent. 5. If archival tumor tissue sample obtained within 36 months prior to study participation is not available, participants should be willing to undergo a biopsy at screening. 6. Life expectancy of at least 12 weeks. 7. ECOG performance status of 0 or 1 at the time of ICF signing. 8. Adequate organ function, as evidenced by the following laboratory values (transfusion and hematopoietic growth factors are not permitted within 14 days before obtaining these laboratory values): 1. ANC ≥ 1.5 × 10⁹/L. 2. Platelet count ≥ 100 × 10⁹/L. 3. Hemoglobin ≥ 90 g/L. 4. ALT ≤ 2.5 × ULN, or ALT ≤ 5 × ULN in the presence of liver metastases. 5. AST ≤ 2.5 × ULN, or AST ≤ 5 × ULN in the presence of liver metastases. 6. Total bilirubin ≤ 1.5 × ULN. 7. Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (measured or calculated per Cockcroft and Gault formula); confirmation of creatinine clearance is only required when creatinine ≥ 1.5 × ULN. 8. Coagulation: INR or PT ≤ 1.5 × ULN. aPTT ≤ 1.5 × ULN (if participant is receiving anticoagulants, the value must be within the therapeutic range for the participant's condition). 9. Males of reproductive potential and females of childbearing potential must agree to use effective contraception from the time of ICF signing until 180 days after the last dose of study drug. Exclusion Criteria: 1. Known active CNS metastases and/or carcinomatous meningitis. 2. Prior treatment with CLDN18.2-targeted therapy or cell therapy, excluding CLDN18.2 monospecific monoclonal antibodies. 3. Prior treatment with any chemotherapy, immunotherapy, anti-cancer drugs, or investigational products from previous clinical studies within 28 days prior to randomization, or within the period required for the investigational product or systemic anti-cancer treatment to be cleared from the body (e.g., 5 "half-lives"), whichever is deemed most appropriate by the Investigator. 4. Received extensive radiotherapy within 28 days prior to randomization, or limited-field radiotherapy for palliative purposes within 14 days prior to the first dose of study treatment. 5. Major surgery within 28 days prior to randomization (excluding placement of vascular access) or minor surgical procedures ≤ 7 days. No waiting period is required after port-a-cath placement and drain insertion. 6. Active autoimmune disease requiring systemic treatment 7. Presence of any severe or uncontrolled systemic disease as judged by the Investigator 8. Complications or other conditions (psychological, family, social, or geographical, etc.) that, in the Investigator's opinion, could affect compliance with the protocol or make the participant unsuitable for the study.

Locations (131)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Fuyang Hospital of Anhui Medical University (The Fifth Affiliated Hospital of Anhui Medical University)

Fuyang, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqi, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Gansu Cancer Hospital

Lanzhou, Gansu, China

Gansu Cancer Hospital

Lanzhou, Gansu, China

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Hainan Cancer Hospital

Haikou, Hainan, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Cangzhou People's Hospital

Cangzhou, Hebei, China

Handan Central Hospital

Handan, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang Second People's Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Sanmenxia Central Hospital

Sanmenxia, Henan, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhumadian Central Hospital

Zhumadian, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Central Hospital

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Peking University Cancer Hospital Inner Mongolia Hospital

Hohhot, Inner Mongolia, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China

Nantong Tumor Hospital

Nantong, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Jilin Cancer Hospital

Changchun, Jilin, China

Chaoyang Central Hospital

Chaoyang, Liaoning, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Shandong Medical and Pharmaceutical University Hospital

Binzhou, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital and Institute, Shandong First Medical University

Jinan, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

The Second Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Tengzhou Central People's Hospital

Tengzhou, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Weihai Municipal Hospital

Weihai, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

The Fourth People Hospital of Zibo(Zibo Infectious Disease Hospital, Zibo Cancer Hospital)

Zibo, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Fudan University Shanghai Cancer Center