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.
Provide signed and dated written informed consent (ICF) before any study-specific procedures, sampling, and analyses.
Age ≥ 18 years at the time of consent.
Histologically or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.
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.
Known active CNS metastases and/or carcinomatous meningitis.
Prior treatment with CLDN18.2-targeted therapy or cell therapy, excluding CLDN18.2 monospecific monoclonal antibodies.
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.
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.
Parallel
ATG-022
Drug1.8 mg/kg,D1, Q3W，every 21 days as one cycle
Docetaxel or Irinotecan
DrugDocetaxel: 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
Progression-Free Survival(PFS )
PFS is defined as the duration from randomization to the first objective documentation of PD or death from any cause
Overall Survival(OS)
Duration from randomization to death from any cause
Objective response rate (ORR)
ORR is Defined as the percentage of participants achieving a CR or PR
Disease control rate (DCR)
DCR is Defined as the percentage of participants achieving CR, PR, or SD ≥ 3 months
Duration of response (DOR)
DOR is defined as the duration from the first meeting of the criteria for CR or PR to the first documented PD or death from any cause
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