NCT07327229RecruitingPhase 1/2
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 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
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- Feb 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Antengene Biologics Limited
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07327229
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 132
- From Feb 2026 to the primary completion date, Sept 2027
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Tumor Hospital Coordinator of this site? Confirm its status | Anyang | China | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Fujian Provincial Cnacer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shandong Cancer Hospital &Institue Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Cancer Institute&Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Langfang | China | Not yet recruiting |
| Gansu Provincial Cnacer Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Tongren Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Medical Universuty Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Xiamen University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tongji Medical college of HUST Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| The First Affiliated Hospital of Henan Medical Hospital Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Not yet recruiting |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| Henan Cnacer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhenghzou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.