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A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

Study acronym: GAMBIT
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Sep 28, 2026 to Aug 14, 2026 Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 3 of 6 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 6 entries
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 14 to 13v7 Show 1 more changeShow less
    • Study sites: 14 to 13
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Minor Study sites: 13 to 14v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Site details revised at 9 of 13 sitesv4
  2. Minor Site details revised at 7 of 13 sitesv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 25, 2025 to Aug 29, 2025 · Site details revised at 13 of 13 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 25, 2025 to Aug 29, 2025
    • Site details revised at 13 of 13 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Trial Details
NCT Number NCT07143604
Lead Sponsor AstraZeneca
Conditions Gastric Cancer, Gastroesophageal Junction Cancer
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov