A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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)
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 (114)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.