RecruitingPhase 3NCT07066098

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

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>=2 Prior Lines of Therapy


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

201 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called IBI343 — an antibody-drug conjugate that delivers cancer-killing chemotherapy directly to cancer cells that carry a specific surface protein called Claudin 18.2 — versus a placebo, in people with advanced pancreatic cancer that has not responded to prior treatments. **You may be eligible if...** - You have been diagnosed with unresectable (cannot be surgically removed) or metastatic pancreatic cancer - Your tumor has tested positive for Claudin 18.2 (a protein on cancer cells the drug targets) - You have already received at least two prior chemotherapy regimens, including one fluorouracil-based and one gemcitabine-based regimen, and the cancer progressed - You are in reasonably good physical condition (ECOG score 0 or 2) - Your blood counts and organ function are in an acceptable range **You may NOT be eligible if...** - You have previously received a topoisomerase inhibitor-based antibody-drug conjugate treatment - You have active brain metastases causing symptoms - You are currently participating in another interventional clinical trial - You have had another active primary cancer recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI343

Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle

DRUGPlacebo

Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07066098


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