A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Antengene Biologics Limited trials in China
Other trials for the same condition
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