A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07795346 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380
Last updated 2026-08-31
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.
Conditions
- Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
ATG-022
1.8 mg/kg,D1, Q3W,every 21 days as one cycle
- DRUG
-
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
Sponsors & Collaborators
-
Antengene Biologics Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
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