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

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 ID
NCT07066098
Phase
PHASE3
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • IBI343
  • Placebo
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
  • Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
  • Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
  • ECOG PS score of 0 or 2.

For full eligibility, visit ClinicalTrials.gov.

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