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
CLINCH-2
3 other identifiers
interventional
132
1 country
30
Brief Summary
This is 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 Adenocarcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2026
Typical duration for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
April 14, 2026
April 1, 2026
1.6 years
December 5, 2025
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
AEs and SAEs
12 months after the last subject enrolled
DLT
Dose Limiting Toxicity
Up to 21 Days
RP2D
RP2D= Recommended Phase 2 Dose
Up to 21 Days
Secondary Outcomes (4)
ORR
12 months after the last subject enrolled
DOR
12 months after the last subject enrolled
PFS
12 months after the last subject enrolled
Plasma concentration of ATG-022 and derived PK paramete
One year after last patient first dose
Study Arms (2)
ATG-022+pembrolizumab/KEYTRUDA®
EXPERIMENTALATG-022+pembrolizumab/KEYTRUDA®+CAPOX
ACTIVE COMPARATORInterventions
1.8mg/kg Q3W, every 21 days as one cycle
20mg Q3W, every 21 days as one cycle
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
You may qualify if:
- Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
- Aged ≥18 years as of the date of consent.
- Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.
- 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.
- At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators.
- Estimated life expectancy of a minimum of 12 weeks.
You may not qualify if:
- Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.
- Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.
- 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.
- 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.
- 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
- Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antengene Biologics Limitedlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (30)
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
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2025
First Posted
January 8, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
April 30, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04