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A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Aug 4, 2025 to Jul 17, 2025 Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 10 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 10 entries
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 31, 2025 to Aug 4, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 31, 2025 to Aug 4, 2025
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.
Trial Details
NCT Number NCT07066098
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Pancreatic Cancer
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov