A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
CLINCH-3
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
1 other identifier
interventional
380
1 country
114
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2026
Typical duration for phase_3
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
August 31, 2026
July 1, 2026
3.3 years
August 25, 2026
August 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival(PFS )
PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
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
From randomization to death. Survival follow-up q3m (±14d) until death/study termination (~228 OS events).
Secondary Outcomes (3)
Objective response rate (ORR)
Proportion with confirmed CR/PR. Based on tumour assessments per schedule (as above). Data cutoff at study completion.
Disease control rate (DCR)
Proportion with CR/PR/SD ≥3 months (confirmed by ≥2 assessments). Assessment schedule as above. Data cutoff at study completion.
Duration of response (DOR)
From first documented CR/PR to first PD or death. Assessment schedule same as PFS. Data cutoff at study completion.
Study Arms (2)
ATG-022
EXPERIMENTALDocetaxel or Irinotecan
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, 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
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 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
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
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
Renmin Hospital of Wuhan University
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
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
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
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 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
Affiliated Hospital of Qinghai University
Xining, Qinghai, China
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong 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
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Nanchong Central Hospital
Nanchang, Sichuan, China
Neijiang Second People's Hospital
Neijiang, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Yibin First People's Hospital
Yibin, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Shanghai Tenth People's Hospital
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
The First Hospital of Shanxi Medical University
Taiyuan, China
Taizhou People's Hospital
Taizhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xuzhou Central Hospital
Xuzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2026
First Posted
August 31, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
August 31, 2026
Record last verified: 2026-07