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A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)

Study acronym: G-HOPE-001
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 450 to confirmed 464 · Study sites: 22 to 95 · Study title expanded, about 1 wordv5 Show 3 more changesShow less
    • Enrollment target: estimated 450 to confirmed 464
    • Study sites: 22 to 95
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Enrolling by Invitation to Recruiting Study sites: 1 to 22 · Interventions: IBI343 (Drug), irinotecan (Drug), paclitaxel (Drug) to IBI343 (Drug), Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） (Drug) · Secondary endpoints: details revised at 1 of 12 entries · 1 morev4 Show 4 more changesShow less
    • Study sites: 1 to 22
    • Interventions: IBI343 (Drug), irinotecan (Drug), paclitaxel (Drug) to IBI343 (Drug), Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） (Drug)
    • Secondary endpoints: details revised at 1 of 12 entries
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 30, 2027 to Dec 30, 2026v3
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary completion date: May 30, 2026 to Jun 30, 2027 · Start date changed from estimate of Mar 29, 2024 to Jun 30, 2024 · Completion date: Jun 30, 2027 to Dec 31, 2027 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: May 30, 2026 to Jun 30, 2027
    • Start date changed from estimate of Mar 29, 2024 to Jun 30, 2024
    • Completion date: Jun 30, 2027 to Dec 31, 2027
    • Site contact updated
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)
Trial Details
NCT Number NCT06238843
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Enrollment 464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov