Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaPhase 1/2CLINCH-2NCT07327229
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
A Phase 1/2 study testing ATG-022, pembrolizumab/KEYTRUDA® and CAPOX in people with Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Antengene Biologics Limited at 30 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- ATG-022, pembrolizumab/KEYTRUDA® and CAPOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 30 sitesChina
- Study dates
- 27 Feb 2026to 30 Apr 2029
- Phase
- Phase 1/2
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang, Henan
Jin Xia
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality
Lin Shen, MD
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Li Zheng, MD
- Recruiting
Fujian Provincial Cnacer Hospital
Fuzhou, Fujian
Rongbo Lin
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Gang Wang
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Kangsheng Gu
- Recruiting
Jinan Central Hospital
Jinan, Shandong
Meili Sun
- Recruiting
Shandong Cancer Hospital &Institue
Jinan, Shandong
Changzheng Li
- Not yet recruiting
Cancer Institute&Hospital Chinese Academy of Medical Sciences
Langfang, Hebei
Yongkun Sun
- Not yet recruiting
Gansu Provincial Cnacer Hospital
Lanzhou, Gansu
Yuhua Liu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Xiaodong Peng
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Xiaofeng Chen
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Jing LV
- Recruiting
Tongren Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Jianjun Zhang
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
funan Liu
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qun Zhao
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
zhixiang Zhuang
- Recruiting
Shanxi provincial cancer hospital
Taiyuan, Shanxi
Jinfeng Ma, MD
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Yusheng Wang
- Recruiting
Tianjin Medical Universuty Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Ting Deng
- Recruiting
The First Affiliated Hospital of Xiamen University
Wenzhou, Zhejiang
Yin Jin
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Xinjun Liang
- Recruiting
Tongji Medical College of HUST
Wuhan, Hubei
Xianglin Yuan
- Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an, Shanxi
Ying Kong
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Jiayi Li
- Recruiting
The First Affiliated Hospital of Henan Medical Hospital
Xinxiang, Henan
Liuzhong Yang
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yuan Yuan
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Ping Chen
- Not yet recruiting
Henan Cnacer Hospital
Zhengzhou, Henan
Xiaobing Chen
- Recruiting
The First Affiliated Hospital of Zhenghzou University
Zhengzhou, Henan
Yanru Qin
About this study
Official title: 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
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
Read the detailed description
This is a phase Ib/II Study of ATG-022 plus pembrolizumab with/without chemotherapy in participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1), unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Both the intervention of ATG022 + Pembrolizumab (A+P) and the intervention of ATG-022 + pembrolizumab + chemotherapy (CAPOX regimen, A+P+C) consist of a Ib and II phase.
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
- Being tested
- ATG-022, pembrolizumab/KEYTRUDA®, CAPOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-022Drug
1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®Drug
20mg Q3W, every 21 days as one cycle
CAPOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ATG-022+pembrolizumab/KEYTRUDA® | Experimental | Not described Receives: Drug: ATG-022; Drug: pembrolizumab/KEYTRUDA® |
| ATG-022+pembrolizumab/KEYTRUDA®+CAPOX | Active comparator | Not described Receives: Drug: ATG-022; Drug: pembrolizumab/KEYTRUDA®; Drug: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs
Measured: 12 months after the last subject enrolled
DLT
Dose Limiting Toxicity
Measured: Up to 21 Days
RP2D
RP2D= Recommended Phase 2 Dose
Measured: Up to 21 Days
Secondary outcomes (4)
ORR
Overall Response Rate
Measured: 12 months after the last subject enrolled
DOR
Duration of Response
Measured: 12 months after the last subject enrolled
PFS
Progression Free Survival
Measured: 12 months after the last subject enrolled
Plasma concentration of ATG-022 and derived PK paramete
To characterize the PK of ATG-022
Measured: One year after last patient first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start27 Feb 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable or Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 1.8 mg/kg Q3W with 1 subject
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antengene Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327229
- Sponsor's protocol ID
- ATG-022-GC-001
- Other IDs
- KEYNOTE-G37, MK-3475-G37
- Acronym
- CLINCH-2
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07327229
- Acronym / sponsor ID
- CLINCH-2 / ATG-022-GC-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Antengene Biologics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 8 Jan 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.
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
Detailed description
This is a phase Ib/II Study of ATG-022 plus pembrolizumab with/without chemotherapy in participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1), unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Both the intervention of ATG022 + Pembrolizumab (A+P) and the intervention of ATG-022 + pembrolizumab + chemotherapy (CAPOX regimen, A+P+C) consist of a Ib and II phase.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 1.8 mg/kg Q3W with 1 subject
| Arm | Type | Receives |
|---|---|---|
| ATG-022+pembrolizumab/KEYTRUDA® | Experimental | Drug: ATG-022, Drug: pembrolizumab/KEYTRUDA® |
| ATG-022+pembrolizumab/KEYTRUDA®+CAPOX | Active comparator | Drug: ATG-022, Drug: pembrolizumab/KEYTRUDA®, Drug: CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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-0221.8mg/kg Q3W, every 21 days as one cycle | Drug | ATG-022+pembrolizumab/KEYTRUDA®, ATG-022+pembrolizumab/KEYTRUDA®+CAPOX |
| pembrolizumab/KEYTRUDA®20mg Q3W, every 21 days as one cycle | Drug | ATG-022+pembrolizumab/KEYTRUDA®, ATG-022+pembrolizumab/KEYTRUDA®+CAPOX |
| CAPOXStandard 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. | Drug | ATG-022+pembrolizumab/KEYTRUDA®+CAPOX |
Primary outcome
AEs and SAEs
Time frame: 12 months after the last subject enrolled
DLT
Time frame: Up to 21 Days
Dose Limiting Toxicity
RP2D
Time frame: Up to 21 Days
RP2D= Recommended Phase 2 Dose
4 secondary outcomes
ORR
Time frame: 12 months after the last subject enrolled
DOR
Time frame: 12 months after the last subject enrolled
PFS
Time frame: 12 months after the last subject enrolled
Plasma concentration of ATG-022 and derived PK paramete
Time frame: One year after last patient first dose
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 Jul 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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATG-022, pembrolizumab/KEYTRUDA® and CAPOX in people with Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Antengene Biologics Limited at 30 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 6 inclusion and 7 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 felix li (182 05191049, felix.li@antengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs (time frame: 12 months after the last subject enrolled). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.