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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.

Phase 3RecruitingAstraZenecaNCT06346392Data as of May 2026

Treatment: AZD0901 · AZD0901 · Ramucirumab+ paclitaxel · Paclitaxel · Docetaxel · Irinotecan · TAS-102 · ApatinibThe 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.

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Extracted 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

Min 1 prior line

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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