Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3CLINCH-3NCT07795346

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

A Phase 3 study testing ATG-022 and Docetaxel or Irinotecan in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Antengene Biologics Limited at 131 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: ATG-022 and Docetaxel or Irinotecan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 131 sitesChina
Study dates: 17 Sep 2026to 31 Dec 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide signed and dated written informed consent (ICF) before any study-specific procedures, sampling, and analyses.
Age ≥ 18 years at the time of consent.
Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.
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.
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.
Life expectancy of at least 12 weeks.

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ECOG performance status of 0 or 1 at the time of ICF signing.
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):
ANC ≥ 1.5 × 10⁹/L.
Platelet count ≥ 100 × 10⁹/L.
Hemoglobin ≥ 90 g/L.
ALT ≤ 2.5 × ULN, or ALT ≤ 5 × ULN in the presence of liver metastases.
AST ≤ 2.5 × ULN, or AST ≤ 5 × ULN in the presence of liver metastases.
Total bilirubin ≤ 1.5 × ULN.
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.
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).
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.

Who cannot join

Known active CNS metastases and/or carcinomatous meningitis.
Prior treatment with CLDN18.2-targeted therapy or cell therapy, excluding CLDN18.2 monospecific monoclonal antibodies.
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.
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.
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.
Active autoimmune disease requiring systemic treatment
Presence of any severe or uncontrolled systemic disease as judged by the Investigator
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.

Trial locations and contacts

131 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Wang contact

17601350610

Sara.wang@antengene.com

City, postcode or hospital

Sites recruiting now only

131 sites in 1 country

China131 sites, 131 recruiting

Anyang Cancer Hospital
Anyang, Henan
Jin Xia
Jin Xia
Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei
Zhiyu Wang
Zhiyu Wang
Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Lin Shen, MD
Lin Shen, MD
Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Wei Deng
Wei Deng
Not yet recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality
Ming Lu
Ming Lu
Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Lin Zhao
Lin Zhao
Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Shikai Wu
Shikai Wu
Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Rui Wang
Rui Wang
Not yet recruiting
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong
Fangling Ning
Fangling Ning
Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Sichen Wei
Sichen Wei
Not yet recruiting
Cangzhou People's Hospital
Cangzhou, Hebei
Yuankai Bo
Yuankai Bo
Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Enyong Dai
Enyong Dai
Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin
Haifeng Liu
Haifeng Liu
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Zhenyang Liu
Zhenyang Liu
Not yet recruiting
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan
Huaxin Duan
Huaxin Duan
Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Yawen Gao
Yawen Gao
Not yet recruiting
Changzhi People's Hospital
Changzhi, Shanxi
Jun Zhao
Jun Zhao
Not yet recruiting
Changzhou First People's Hospital
Changzhou, Jiangsu
Jun Wu
Jun Wu
Not yet recruiting
Chaoyang Central Hospital
Chaoyang, Liaoning
Xiujie Cui
Xiujie Cui
Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Hongfeng Gou
Hongfeng Gou
Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqi, Chongqing Municipality
Jun Zhang
Jun Zhang
Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Jie Zhang
Jie Zhang
Not yet recruiting
Fuyang Hospital of Anhui Medical University (The Fifth Affiliated Hospital of Anhui Medical University)
Fuyang, Anhui
Yingying Du
Yingying Du
Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Rongbo Lin, MD
Rongbo Lin, MD
Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Xiaoyan Lin
Xiaoyan Lin
Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Zhenhua Liu, MD
Zhenhua Liu, MD
Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Xi Shi
Xi Shi
Not yet recruiting
Ganzhou Cancer Hospital
Ganzhou, Jiangxi
Qinghua Pan
Qinghua Pan
Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi
Weiwei Peng
Weiwei Peng
Not yet recruiting
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Li Huang
Li Huang
Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Jian Xiao
Jian Xiao
Not yet recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Lizhu Lin
Lizhu Lin
Not yet recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong
Shirong Cai
Shirong Cai
Not yet recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Min Dong
Min Dong
Not yet recruiting
Hainan Cancer Hospital
Haikou, Hainan
Haifeng Li
Haifeng Li, MD
Not yet recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Rucai Li, MD
Rucai LI, MD
Not yet recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Erxia He
Erxia He, MD
Not yet recruiting
Handan Central Hospital
Handan, Hebei
Zheng Liu
Zheng Liu
Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Haizhou Lou
Haizhou Lou
Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Haiping Jiang
Haiping Jiang
Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Jieer Ying
Jieer Ying
Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yiping Mou
Yiping Mou
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yanqiao Zhang
Yanqiao Zhang
Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Kangsheng Gu
Kangsheng Gu
Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui
Gang Wang
Gang Wang
Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Mingjun Zhang
Mingjun Zhang
Not yet recruiting
Peking University Cancer Hospital Inner Mongolia Hospital
Hohhot, Inner Mongolia
Xiaotian Zhang
Xiaotian Zhang
Not yet recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
Yong Gao
Yong Gao
Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Yunhai Wei
Yunhai Wei
Not yet recruiting
Jiangyin People's Hospital
Jiangyin, Jiangsu
Qiong Wang
Qiong Wang
Not yet recruiting
Jiaxing Second Hospital
Jiaxing, Zhejiang
Yaohua Fan
Yaohua Fan
Not yet recruiting
Jinan Central Hospital
Jinan, Shandong
Meili Sun
Meili Sun
Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Hong Liu
Hong Liu
Not yet recruiting
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan, Shandong
Huan Shi
Huan Shi
Not yet recruiting
The Second Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
Haiyan Liu
Haiyan Liu
Not yet recruiting
The Second Hospital of Shandong University
Jinan, Shandong
Haiqun Lin
Haiqun Lin
Not yet recruiting
Jinhua Central Hospital
Jinhua, Zhejiang
Jianfei Fu
Jianfei Fu
Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Wenjing Zhang
Wenjing Zhang
Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Lin Xie
Lin Xie
Not yet recruiting
Gansu Cancer Hospital
Lanzhou, Gansu
Zhihu Li
Zhihu Li
Not yet recruiting
Gansu Cancer Hospital
Lanzhou, Gansu
Yuhua Liu
Yuhua Liu
Not yet recruiting
Gansu Provincial People's Hospital
Lanzhou, Gansu
Mingxu Da
Mingxu Da
Not yet recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Baozhong Wang
Baozhong Wang
Not yet recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang
Qunyi Guo
Qunyi Guo
Not yet recruiting
Lishui Central Hospital
Lishui, Zhejiang
Yanru Xie
Yanru XIe
Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Jun Yao
Jun Yao
Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Huiqing Zhang
Huiqing Zhang
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yong Li
Yong Li
Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Hua Wang
Hua Wang
Not yet recruiting
Nanchong Central Hospital
Nanchang, Sichuan
Yonghong Sun
Yonghong Sun
Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Delin Liu
Delin Liu
Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu
Xiaofeng Chen
Xiaofeng Chen
Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Lei Yang
Lei Yang
Not yet recruiting
Nanyang Second People's Hospital
Nanyang, Henan
Miao Wang
Miao Wang
Not yet recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
Xiuli Yang
Xiuli Yang
Not yet recruiting
Neijiang Second People's Hospital
Neijiang, Sichuan
Yu Liu
Yu Liu
Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi
Zhiqiang Zhan
Zhiqiang Zhan
Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Jing LV
Jing Lv
Not yet recruiting
Sanmenxia Central Hospital
Sanmenxia, Henan
Chuntao Tian
Chuntao Tian
Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Xiaodong Zhu
Xiaodong Zhu
Not yet recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Xiaohua Liang
Xiaohua Liang
Not yet recruiting
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality
Jun Zhou
Jun Zhou
Not yet recruiting
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality
Ning Wu
Ning Wu
Not yet recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality
Jianjun Zhang
Jianjun Zhang
Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Tianshu Liu
Tianshu Liu
Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai
Junli Xue
Junli Xue
Not yet recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong
Yi Jiang
Yi Jiang
Not yet recruiting
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang, Liaoning
Jingdong Zhang
Jingdong Zhang
Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Jing Liu
Jing Liu
Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Jinglei Qu
Jinglei Qu
Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Shubin Wang
Shubin Wang
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Fengbin Zhang
Fengbin Zhang
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qun Zhao
Qun Zhao
Not yet recruiting
Suining Central Hospital
Suining, Sichuan
Na Li
Na Li
Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
Zhixiang Zhuang
Zhixiang Zhuang
Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Yarong Guo
Yarong Guo
Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Jinfeng Ma
Jinfeng Ma
Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan
Yusheng Wang
Yusheng Wang
Not yet recruiting
Taizhou People's Hospital
Taizhou
Gaohua Han
Gaohua Han
Not yet recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong
Ling Li
Ling Li
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Ting Deng
Ting Deng
Not yet recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Yanli Qu, MD
Yanli Qu, MD
Not yet recruiting
Weifang People's Hospital
Weifang, Shandong
Yanfang Gao
Yanfang Gao
Not yet recruiting
Weihai Municipal Hospital
Weihai, Shandong
Ruilin Li
Ruilin Li
Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Yin Jin
Yin Jin
Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Shaozhong Wei
Shaozhong Wei
Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Long Wu
Long Wu
Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xianglin Yuan
Xianglin Yuan
Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Hongli Liu
Hongli Liu, MD
Not yet recruiting
Wuhan Central Hospital
Wuhan, Hubei
Hongli Lu
Hongli Lu, MD
Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Yongchang Wei
Yongchang Wei, MD
Not yet recruiting
Gansu Wuwei Tumour Hospital
Wuwei, Gansu
Peng Nie
Peng Nie
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Aili Suo
Aili Suo
Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Jiayi Li
Jiayi Li
Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Wei Gong
Wei Gong
Not yet recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan
Weizheng Kou
Weizheng Kou
Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Zhengxiang Han
Zhengxiang Han
Not yet recruiting
Xuzhou Central Hospital
Xuzhou
Yuan Yuan
Yuan Yuan
Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
Xianwen Zhang
Xianwen Zhang
Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Jian Chen
Jian Chen
Not yet recruiting
Yibin First People's Hospital
Yibin, Sichuan
Zhiping Yuan
Zhiping Yuan
Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Ping Chen
Ping Chen
Not yet recruiting
The First People's Hospital of Yinchuan
Yinchuan, Ningxia
Yongsheng Zhao, MD
Yongsheng Zhao, MD
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Jufeng Wang
Jufeng Wang
Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Chuangxin Lu
Chuangxin Lu
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Hong Zong
Hong Zong
Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Jian Wang
Jian Wang
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Yanru Qin
Yanru Qin
Not yet recruiting
Zhumadian Central Hospital
Zhumadian, Henan
Yunfang Chen
Yunfang Chen
Not yet recruiting
The Fourth People Hospital of Zibo(Zibo Infectious Disease Hospital, Zibo Cancer Hospital)
Zibo, Shandong
Keshan Wang
Keshan Wang
Not yet recruiting
Zibo Central Hospital
Zibo, Shandong
Yi Zhai
Yi Zhai
Not yet recruiting

Other trials in China

About this study

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

Read the detailed description

This study is based on the positive data for ATG-022 monotherapy in CLDN18.2-positive advanced gastric/GEJ adenocarcinoma obtained from the CLINCH study. Through PopPK and exposure-response (E-R) analysis of ATG-022, this study will use ATG-022 monotherapy at 1.8 mg/kg compared to Investigator's Choice to evaluate the efficacy and safety of the two treatment regimens in participants with advanced gastric/GEJ adenocarcinoma who have received prior second-line systemic therapy. The Investigator's Choice regimen includes two optional drugs: Docetaxel or Irinotecan. Both docetaxel and irinotecan are commonly used single-agent chemotherapy drugs in third-line treatment for gastric cancer.

Conditions: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: ATG-022, Docetaxel or Irinotecan
Keywords: Advanced Gastric, Gastroesophageal Junction Adenocarcinoma, CLDN18.2 positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ATG-022Drug
1.8 mg/kg,D1, Q3W，every 21 days as one cycle
Docetaxel or IrinotecanDrug
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

Study groups in NCT07795346
Study group	Role	What they receive
ATG-022	Experimental	Not described Receives: Drug: ATG-022
Docetaxel or Irinotecan	Active comparator	Not described Receives: Drug: Docetaxel or Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival(PFS )
PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
Measured: From randomization to first PD or death. Tumour assessments at baseline, q6w (±1w) during treatment, q12w (±1w) after 12m, q24w (±1w) after 24m, until PD/death/study end (~228 OS events, ~1yr after LPI).
Overall Survival(OS)
Duration from randomization to death from any cause
Measured: From randomization to death. Survival follow-up q3m (±14d) until death/study termination (~228 OS events).

Secondary outcomes (3)

Objective response rate (ORR)
ORR is Defined as the percentage of participants achieving a CR or PR
Measured: Proportion with confirmed CR/PR. Based on tumour assessments per schedule (as above). Data cutoff at study completion.
Disease control rate (DCR)
DCR is Defined as the percentage of participants achieving CR, PR, or SD ≥ 3 months
Measured: Proportion with CR/PR/SD ≥3 months (confirmed by ≥2 assessments). Assessment schedule as above. Data cutoff at study completion.
Duration of response (DOR)
DOR is defined as the duration from the first meeting of the criteria for CR or PR to the first documented PD or death from any cause
Measured: From first documented CR/PR to first PD or death. Assessment schedule same as PFS. Data cutoff at study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202631 Dec 2029

First posted31 Aug 2026
Study start17 Sep 2026
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 380 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07795346
Sponsor's protocol ID: ATG-022-GC-002
Acronym: CLINCH-3
Status last verified: Jul 2026
First submitted: 25 Aug 2026
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07795346
Acronym / sponsor ID: CLINCH-3 / ATG-022-GC-002
Conditions: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Keywords: Advanced Gastric, Gastroesophageal Junction Adenocarcinoma, CLDN18.2 positive
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 380 participants (estimated)
Lead sponsor: Antengene Biologics LimitedIndustry (pharma, biotech, devices)
Study start: 17 Sep 2026 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 31 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ATG-022	Experimental	Drug: ATG-022
Docetaxel or Irinotecan	Active comparator	Drug: Docetaxel or Irinotecan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Provide signed and dated written informed consent (ICF) before any study-specific procedures, sampling, and analyses.
Age ≥ 18 years at the time of consent.
Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.
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.
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.

Key exclusion criteria (8 listed)

Known active CNS metastases and/or carcinomatous meningitis.
Prior treatment with CLDN18.2-targeted therapy or cell therapy, excluding CLDN18.2 monospecific monoclonal antibodies.
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.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ATG-0221.8 mg/kg,D1, Q3W，every 21 days as one cycle	Drug	ATG-022
Docetaxel or IrinotecanDocetaxel: 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	Drug	Docetaxel or Irinotecan

Primary outcome

Progression-Free Survival(PFS )
Time frame: From randomization to first PD or death. Tumour assessments at baseline, q6w (±1w) during treatment, q12w (±1w) after 12m, q24w (±1w) after 24m, until PD/death/study end (~228 OS events, ~1yr after LPI).
PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
Overall Survival(OS)
Time frame: From randomization to death. Survival follow-up q3m (±14d) until death/study termination (~228 OS events).
Duration from randomization to death from any cause

3 secondary outcomes

Objective response rate (ORR)
Time frame: Proportion with confirmed CR/PR. Based on tumour assessments per schedule (as above). Data cutoff at study completion.
Disease control rate (DCR)
Time frame: Proportion with CR/PR/SD ≥3 months (confirmed by ≥2 assessments). Assessment schedule as above. Data cutoff at study completion.
Duration of response (DOR)
Time frame: From first documented CR/PR to first PD or death. Assessment schedule same as PFS. Data cutoff at study completion.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sara Wang contact

17601350610

Sara.wang@antengene.com

131 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ATG-022 and Docetaxel or Irinotecan in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Antengene Biologics Limited at 131 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Wang (17601350610, Sara.wang@antengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival(PFS ) (time frame: From randomization to first PD or death. Tumour assessments at baseline, q6w (±1w) during treatment, q12w (±1w) after 12m, q24w (±1w) after 24m, until PD/death/study end (~228 OS events, ~1yr after LPI).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07795346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.