OncoMatch/Clinical Trials/NCT06346392
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
Is NCT06346392 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for gastric cancer.
Treatment: AZD0901 · AZD0901 · Ramucirumab+ paclitaxel · Paclitaxel · Docetaxel · Irinotecan · TAS-102 · Apatinib — The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 positive expression
Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+/ISH+ (HER2:CEP17 ratio ≥ 2 or average HER2 copy number ≥ 6.0 signals/cell))
Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH) [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine — advanced or metastatic
Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum
Must have received: platinum-based chemotherapy — advanced or metastatic
Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum
Cannot have received: antibody-drug conjugate
Exception: ADC with MMAE payload
Prior exposure to any ADC with MMAE payload
Cannot have received: CLDN18.2 targeting treatment
Exception: naked monoclonal antibody
Prior exposure to any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc)
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
Liver function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Birmingham, Alabama
- Research Site · Mobile, Alabama
- Research Site · Tucson, Arizona
- Research Site · Duarte, California
- Research Site · Fullerton, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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