Can a targeted drug outperform chemotherapy for stomach cancer?

NCT ID NCT07795346

Disease control Sponsor: Antengene Biologics Limited Source: ClinicalTrials.gov ↗

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether an experimental drug called ATG-022 can slow the growth of advanced stomach or gastroesophageal junction cancer better than standard chemotherapy. The study enrolls adults whose tumors show a specific marker called CLDN18.2 and who have already tried at least two prior treatments. Participants receive either ATG-022 or a standard chemotherapy drug chosen by their doctor. Researchers will measure how long people live without their cancer progressing and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ATG-022, an experimental drug targeting CLDN18.2, compared with standard chemotherapy (docetaxel or irinotecan)
What this could lead to: If ATG-022 works, it could offer a new, more effective treatment option for people with advanced gastric cancer that has stopped responding to earlier therapies.
What could go wrong: This is a phase III trial, but success is not guaranteed. ATG-022 may not improve survival or could cause side effects that outweigh its benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced gastric or gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

114 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China
Affiliated Hospital of Hebei University

Baoding, Hebei, China
Affiliated Hospital of Qinghai University

Xining, Qinghai, China
Anyang Cancer Hospital

Anyang, Henan, 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
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)

Shenyang, Liaoning, China
Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China
Cangzhou Central Hospital

Cangzhou, Hebei, China
Cangzhou People's Hospital

Cangzhou, Hebei, China
Changzhou First People's Hospital

Changzhou, Jiangsu, China
Chaoyang Central Hospital

Chaoyang, Liaoning, China
China-Japan Union Hospital of Jilin University

Changchun, Jilin, China
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China
Fujian Cancer Hospital

Fuzhou, Fujian, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, China
Fujian Provincial Hospital

Fuzhou, Fujian, China
Gansu Cancer Hospital

Lanzhou, Gansu, China
Gansu Provincial People's Hospital

Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China
Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China
Ganzhou People's Hospital

Ganzhou, Jiangxi, China
General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China
Hainan Cancer Hospital

Haikou, Hainan, China
Handan Central Hospital

Handan, Hebei, China
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Henan Provincial People's Hospital

Zhengzhou, Henan, China
Huai'an First People's Hospital

Huai'an, Jiangsu, China
Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China
Hunan Cancer Hospital

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

Changsha, Hunan, China
Huzhou Central Hospital

Huzhou, Zhejiang, China
Jiangxi Cancer Hospital

Nanchang, Jiangxi, China
Jiangyin People's Hospital

Jiangyin, Jiangsu, China
Jiaxing Second Hospital

Jiaxing, Zhejiang, China
Jilin Cancer Hospital

Changchun, Jilin, China
Jinan Central Hospital

Jinan, Shandong, China
Jinhua Central Hospital

Jinhua, Zhejiang, China
Liaocheng People's Hospital

Liaocheng, Shandong, China
Lishui Central Hospital

Lishui, Zhejiang, China
Nanchong Central Hospital

Nanchang, Sichuan, China
Nantong Tumor Hospital

Nantong, Jiangsu, China
Nanyang Second People's Hospital

Nanyang, Henan, China
Neijiang Second People's Hospital

Neijiang, Sichuan, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, China
Peking University Shenzhen Hospital

Shenzhen, Guangdong, China
Pingxiang People's Hospital

Pingxiang, Jiangxi, China
Qilu Hospital of Shandong University

Jinan, Shandong, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, China
Sanmenxia Central Hospital

Sanmenxia, Henan, China
Shandong Medical and Pharmaceutical University Hospital

Binzhou, Shandong, China
Shanghai GoBroad Cancer Hospital

Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area Gongli Hospital

Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital

Shanghai, China
Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital

Taiyuan, Shanxi, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
Suining Central Hospital

Suining, Sichuan, China
Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China
Taizhou People's Hospital

Taizhou, China
Tengzhou Central People's Hospital

Tengzhou, Shandong, China
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Chongqing Medical University

Chongqi, Chongqing Municipality, China
The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China
The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China
The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China
The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanyang Medical College

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

Hefei, Anhui, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China
The First Affiliated Hospital of Xiamen University

Xiamen, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The First Hospital of Shanxi Medical University

Taiyuan, China
The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China
The First People's Hospital of Yunnan Province

Kunming, Yunnan, China
The Fourth Hospital of Hebei Medical University

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

Zibo, Shandong, China
The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The Second Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China
The Second Affiliated Hospital of Soochow University

Suzhou, China
The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The Second Hospital of Shandong University

Jinan, Shandong, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
Tianjin Medical University Cancer Institute & Hospital

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

Wuhan, Hubei, China
Weifang People's Hospital

Weifang, Shandong, China
Weihai Municipal Hospital

Weihai, Shandong, China
Wuhan Central Hospital

Wuhan, Hubei, China
Xiangyang Central Hospital

Xiangyang, Hubei, China
Xuzhou Central Hospital

Xuzhou, China
Yantai Yuhuangding Hospital

Yantai, Shandong, China
Yibin First People's Hospital

Yibin, Sichuan, China
Yunnan Cancer Hospital

Kunming, Yunnan, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China
Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China
Zhumadian Central Hospital

Zhumadian, Henan, China
Zibo Central Hospital

Zibo, Shandong, China

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