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. It is planned to enroll 201 participants, and participants will be randomized to receive IBI343 plus BSC or placebo plus BSC in a 2:1 ratio.

Inclusion 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.
• Adequate bone marrow and organ function
• Confirmed as CLDN18.2 positive.

Exclusion criteria

• Participation in another interventional study, except observational or post-intervention follow-up.
• Prior treatment with topoisomerase inhibitor-based ADC.
• Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
• Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed) .
• Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
• History of other primary malignancies, except cured or low-risk of recurrence.