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Recruiting 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
Phase
Phase 3
Started
2026-09-17
Last updated
2026-10-29

Condition(s) studied

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

ATG-022 →Docetaxel or IrinotecanAll Docetaxel trials (275) →All Irinotecan trials (157) →

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)

  • Progression-Free Survival(PFS ) — From randomization to first PD or death. Tumour assessments at baseline, q6w (±1w) during treatment, q12w (±1w) after 12m, q24w (±1w) after 24m, until PD/death/study end (~228 OS events, ~1yr after LPI).
    PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
  • Overall Survival(OS) — From randomization to death. Survival follow-up q3m (±14d) until death/study termination (~228 OS events).
    Duration from randomization to death from any cause

Trial sites (131)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui Not Yet Recruiting
Fuyang Hospital of Anhui Medical University (The Fifth Affiliated Hospital of Anhui Medical University) Fuyang Anhui Not Yet Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui Not Yet Recruiting
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Beijing GoBroad Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqi Chongqing Municipality Not Yet Recruiting
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Not Yet Recruiting
Fujian Provincial Hospital Fuzhou Fujian Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Gansu Cancer Hospital Lanzhou Gansu Not Yet Recruiting
Gansu Cancer Hospital Lanzhou Gansu Not Yet Recruiting
Gansu Provincial People's Hospital Lanzhou Gansu Not Yet Recruiting
Gansu Wuwei Tumour Hospital Wuwei Gansu Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
The Third Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
Cancer Hospital of Shantou University Medical College Shantou Guangdong Not Yet Recruiting
Peking University Shenzhen Hospital Shenzhen Guangdong Not Yet Recruiting
Hainan Cancer Hospital Haikou Hainan Not Yet Recruiting
The First Affiliated Hospital of Hainan Medical University Haikou Hainan Not Yet Recruiting
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan Not Yet Recruiting
Affiliated Hospital of Hebei University Baoding Hebei Not Yet Recruiting
Cangzhou Central Hospital Cangzhou Hebei Not Yet Recruiting
Cangzhou People's Hospital Cangzhou Hebei Not Yet Recruiting
Handan Central Hospital Handan Hebei Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Not Yet Recruiting
Anyang Cancer Hospital Anyang Henan Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Not Yet Recruiting
Nanyang Second People's Hospital Nanyang Henan Not Yet Recruiting
The First Affiliated Hospital of Nanyang Medical College Nanyang Henan Not Yet Recruiting
Sanmenxia Central Hospital Sanmenxia Henan Not Yet Recruiting

+ 91 more sites — see the full list on the official registry below.

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