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Clinical Trials in China / NCT07795346
Starting soon Phase 3

A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07795346 · tracked via the Priya Life Science China tracker
Sponsor
Antengene Biologics Limited
Phase
Phase 3
Started
2026-09-01
Last updated
2026-08-31

Condition(s) studied

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

ATG-022Docetaxel or Irinotecan

ATG-022: 1.8 mg/kg,D1, Q3W,every 21 days as one cycle

Docetaxel or Irinotecan: Docetaxel: 75-100 mg/m², D1, Q3W, every 21 days as one cycle Irinotecan: 125 mg/m², D1, D8, Q3W, every 21 days as one cycle

Study summary

This is a randomized, controlled, open-label, multicenter Phase III study to evaluate the efficacy and safety of ATG-022 compared with Investigator's Choice in participants with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Provide signed and dated written informed consent (ICF) before any study-specific procedures, sampling, and analyses. 2. Age ≥ 18 years at the time of consent. 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression. 4. Disease progression after at least second-line and no more than fourth-line systemic therapy. Prior therapy must have included a fluoropyrimidine and a platinum agent. 5. If archival tumor tissue sample obtained within 36 months prior to study participation is not available, participants should be willing to undergo a biopsy at screening. 6. Life expectancy of at least 12 weeks. 7. ECOG performance status of 0 or 1 at the time of ICF signing. 8. Adequate organ function, as evidenced by the following laboratory values (transfusion and hematopoietic growth factors are not permitted within 14 days before obtaining these laboratory values): 1. ANC ≥ 1.5 × 10⁹/L. 2. Platelet count ≥ 100 × 10⁹/L. 3. Hemoglobin ≥ 90 g/L. 4. ALT ≤ 2.5 × ULN, or ALT ≤ 5 × ULN in the presence of liver metastases. 5. AST ≤ 2.5 × ULN, or AST ≤ 5 × ULN in the presence of liver metastases. 6. Total bilirubin ≤ 1.5 × ULN. 7. Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (measured or calculated per Cockcroft and Gault formula); confirmation of creatinine clearance is only required when creatinine ≥ 1.5 × ULN. 8. Coagulation: INR or PT ≤ 1.5 × ULN. aPTT ≤ 1.5 × ULN (if participant is receiving anticoagulants, the value must be within the therapeutic range for the participant's condition). 9. Males of reproductive potential and females of childbearing potential must agree to use effective contraception from the time of ICF signing until 180 days after the last dose of study drug. Exclusion Criteria: 1. Known active CNS metastases and/or carcinomatous meningitis. 2. Prior treatment with CLDN18.2-targeted therapy or cell therapy, excluding CLDN18.2 monospecific monoclonal antibodies. 3. Prior treatment with any chemotherapy, immunotherapy, anti-cancer drugs, or investigational products from previous clinical studies within 28 days prior to randomization, or within the period required for the investigational product or systemic anti-cancer treatment to be cleared from the body (e.g., 5 "half-lives"), whichever is deemed most appropriate by the Investigator. 4. Received extensive radiotherapy within 28 days prior to randomization, or limited-field radiotherapy for palliative purposes within 14 days prior to the first dose of study treatment. 5. Major surgery within 28 days prior to randomization (excluding placement of vascular access) or minor surgical procedures ≤ 7 days. No waiting period is required after port-a-cath placement and drain insertion. 6. Active autoimmune disease requiring systemic treatment 7. Presence of any severe or uncontrolled systemic disease as judged by the Investigator 8. Complications or other conditions (psychological, family, social, or geographical, etc.) that, in the Investigator's opinion, could affect compliance with the protocol or make the participant unsuitable for the study.

Primary outcome measure(s)

Trial sites (114)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui
Beijing Cancer Hospital Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Beijing GoBroad Hospital Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqi Chongqing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Fujian Medical University Union Hospital Fuzhou Fujian
Fujian Provincial Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Gansu Cancer Hospital Lanzhou Gansu
Gansu Provincial People's Hospital Lanzhou Gansu
Gansu Wuwei Tumour Hospital Wuwei Gansu
Guangdong Provincial People's Hospital Guangzhou Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong
Cancer Hospital of Shantou University Medical College Shantou Guangdong
Peking University Shenzhen Hospital Shenzhen Guangdong
Hainan Cancer Hospital Haikou Hainan
The First Affiliated Hospital of Hainan Medical University Haikou Hainan
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan
Affiliated Hospital of Hebei University Baoding Hebei
Cangzhou Central Hospital Cangzhou Hebei
Cangzhou People's Hospital Cangzhou Hebei
Handan Central Hospital Handan Hebei
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Anyang Cancer Hospital Anyang Henan
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Nanyang Second People's Hospital Nanyang Henan
The First Affiliated Hospital of Nanyang Medical College Nanyang Henan
Sanmenxia Central Hospital Sanmenxia Henan
The First Affiliated Hospital of Henan Medical University Xinxiang Henan
Henan Cancer Hospital Zhengzhou Henan
Henan Provincial People's Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Zhumadian Central Hospital Zhumadian Henan

+ 74 more sites — see the full list on the official registry below.

More Antengene Biologics Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07795346 on ClinicalTrials.gov ↗ ← All trials in China