CClinicalTrials.gg
RecruitingNCT07327229CLINCH-2Updated Jul 29, 2026

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 interventional study of ATG-022 and pembrolizumab/KEYTRUDA® in Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, sponsored by Antengene Biologics Limited. Recruiting at 30 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Antengene Biologics Limited · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
132
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
03

In context

Lead sponsor

Antengene Biologics Limited is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
  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

Exclusion Criteria:

  1. 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.
  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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    ATG-022+pembrolizumab/KEYTRUDA®

    Drug: ATG-022 · Drug: pembrolizumab/KEYTRUDA®

  • Active comparator
    ATG-022+pembrolizumab/KEYTRUDA®+CAPOX

    Drug: ATG-022 · Drug: pembrolizumab/KEYTRUDA® · Drug: CAPOX

Interventions

  • DrugATG-022

    1.8mg/kg Q3W, every 21 days as one cycle

  • Drugpembrolizumab/KEYTRUDA®

    20mg Q3W, every 21 days as one cycle

  • DrugCAPOX

    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.

06

What researchers measure

Primary outcomes

  1. AEs and SAEs

    Time frame: 12 months after the last subject enrolled

  2. DLT

    Dose Limiting Toxicity

    Time frame: Up to 21 Days

  3. RP2D

    RP2D= Recommended Phase 2 Dose

    Time frame: Up to 21 Days

Secondary outcomes

  1. ORR

    Overall Response Rate

    Time frame: 12 months after the last subject enrolled

  2. DOR

    Duration of Response

    Time frame: 12 months after the last subject enrolled

  3. PFS

    Progression Free Survival

    Time frame: 12 months after the last subject enrolled

  4. Plasma concentration of ATG-022 and derived PK paramete

    To characterize the PK of ATG-022

    Time frame: One year after last patient first dose

07

Study locations

26 of 30 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui, China
    • Gang Wang · Contact
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
    • Kangsheng Gu · Contact
    Recruiting
  • Beijing Cancer hospital
    Beijing, Beijing Municipality, China
    • Lin Shen, MD · Contact
    Recruiting
  • Fujian Provincial Cnacer Hospital
    Fuzhou, Fujian, China
    • Rongbo Lin · Contact
    Recruiting
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian, China
    • Jiayi Li · Contact
    Recruiting
  • Gansu Provincial Cnacer Hospital
    Lanzhou, Gansu, China
    • Yuhua Liu · Contact
    Not yet recruiting
  • Cancer Institute&Hospital Chinese Academy of Medical Sciences
    Langfang, Hebei, China
    • Yongkun Sun · Contact
    Not yet recruiting
  • The Fourth Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    • Qun Zhao · Contact
    Recruiting
  • Anyang Tumor Hospital
    Anyang, Henan, China
    • Jin Xia · Contact
    Recruiting
  • The First Affiliated Hospital of Henan Medical Hospital
    Xinxiang, Henan, China
    • Liuzhong Yang · Contact
    Recruiting
  • Henan Cnacer Hospital
    Zhengzhou, Henan, China
    • Xiaobing Chen · Contact
    Not yet recruiting
  • The First Affiliated Hospital of Zhenghzou University
    Zhengzhou, Henan, China
    • Yanru Qin · Contact
    Recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei, China
    • Xinjun Liang · Contact
    Recruiting
  • Tongji Medical College of HUST
    Wuhan, Hubei, China
    • Xianglin Yuan · Contact
    Recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
    • Xiaofeng Chen · Contact
    Recruiting
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    • zhixiang Zhuang · Contact
    Recruiting
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu, China
    • Yuan Yuan · Contact
    Not yet recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    • Xiaodong Peng · Contact
    Recruiting
  • The First Hospital of China Medical University
    Shenyang, Liaoning, China
    • funan Liu · Contact
    Recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia, China
    • Ping Chen · Contact
    Recruiting
  • Jinan Central Hospital
    Jinan, Shandong, China
    • Meili Sun · Contact
    Recruiting
  • Shandong Cancer Hospital &Institue
    Jinan, Shandong, China
    • Changzheng Li · Contact
    Recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
    • Jing LV · Contact
    Recruiting
  • Tongren Hospital Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai Municipality, China
    • Jianjun Zhang · Contact
    Recruiting
  • Shanxi provincial cancer hospital
    Taiyuan, Shanxi, China
    • Jinfeng Ma, MD · Contact
    Recruiting
  • The First Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
    • Yusheng Wang · Contact
    Recruiting
  • The First Affiliated Hospital of XI'AN Jiaotong University
    Xi’an, Shanxi, China
    • Ying Kong · Contact
    Recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan, China
    • Li Zheng, MD · Contact
    Recruiting
  • Tianjin Medical Universuty Cancer Institute & Hospital
    Tianjin, Tianjin Municipality, China
    • Ting Deng · Contact
    Recruiting
  • The First Affiliated Hospital of Xiamen University
    Wenzhou, Zhejiang, China
    • Yin Jin · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07327229
Lead sponsor
Antengene Biologics Limited
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 8, 2026
Start date
Feb 27, 2026
Primary completion
Sep 30, 2027 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Jul 29, 2026

Study contacts

felix li
Contact
felix.li@antengene.com
182 05191049
Jasmine Sun
Contact
jasmine.sun@antengene.com
021-32501095

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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