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
NCT ID: NCT07327229
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
132 participants
INTERVENTIONAL
2026-03-01
2029-04-30
Brief Summary
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Detailed Description
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Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having progressed on or after at least one prior systemic therapy, will be enrolled in the intervention of A + P.
Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having not received any prior systemic therapy, will be enrolled in the intervention of A + P + C. The study will be firstly initiated from Ib of the intervention of A+P. The initiation of the intervention of A+P+C will be based on the clinical data of A+P
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ATG-022+pembrolizumab/KEYTRUDA®
ATG-022
1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®
20mg Q3W, every 21 days as one cycle
ATG-022+pembrolizumab/KEYTRUDA®+CAPOX
ATG-022
1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®
20mg Q3W, every 21 days as one cycle
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.
Interventions
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ATG-022
1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®
20mg Q3W, every 21 days as one cycle
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.
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years as of the date of consent.
3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.
4. Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria.
5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators.
6. Estimated life expectancy of a minimum of 12 weeks.
Exclusion Criteria
2. Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.
3. Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator.
4. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
5. Prior radiotherapy within 4 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. Two weeks or fewer of palliative radiotherapy for non- central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention
6. Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
7. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures≤7 days. No waiting is required following implantable port and catheter placement.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Antengene Biologics Limited
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Gang Wang
Role: primary
Kangsheng Gu
Role: primary
Lin Shen, MD
Role: primary
Rongbo Lin
Role: primary
Jiayi Li
Role: primary
Yuhua Liu
Role: primary
Yongkun Sun
Role: primary
Qun Zhao
Role: primary
Jin Xia
Role: primary
Liuzhong Yang
Role: primary
Xiaobing Chen
Role: primary
Yanru Qin
Role: primary
Xinjun Liang
Role: primary
Xianglin Yuan
Role: primary
Xiaofeng Chen
Role: primary
zhixiang Zhuang
Role: primary
Yuan Yuan
Role: primary
Xiaodong Peng
Role: primary
funan Liu
Role: primary
Ping Chen
Role: primary
Meili Sun
Role: primary
Changzheng Li
Role: primary
Jing LV
Role: primary
Jianjun Zhang
Role: primary
Jinfeng Ma, MD
Role: primary
Yusheng Wang
Role: primary
Ying Kong
Role: primary
Li Zheng, MD
Role: primary
Ting Deng
Role: primary
Yin Jin
Role: primary
Other Identifiers
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KEYNOTE-G37
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-G37
Identifier Type: OTHER
Identifier Source: secondary_id
ATG-022-GC-001
Identifier Type: -
Identifier Source: org_study_id
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