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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI343 for people with a specific type of pancreatic cancer that tests positive for a protein called CLDN18.2. The study will compare IBI343 combined with the best supportive care (which means treatments to help manage symptoms) to a placebo (a treatment without the active drug) plus the same supportive care. The goal is to see if IBI343 can help people live longer compared to those who do not receive the drug. This study is for patients whose cancer has advanced and cannot be removed by surgery or has spread to other parts of the body, and who have already tried at least two other chemotherapy treatments.

People who might be eligible for this study are adults with this specific pancreatic cancer type, who have a good enough overall health status to participate, and whose cancer has continued to grow after previous treatments. They must have tested positive for the CLDN18.2 protein and meet certain health requirements, including good bone marrow and organ function. During the trial, participants will receive either IBI343 or a placebo along with care to help ease symptoms, and they will have regular visits to monitor their health and response to treatment. It’s important to know that this study is not yet open for enrollment, and some people won’t be eligible, such as those currently receiving other cancer treatments or who have certain other medical conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
• • 2. Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
• • 3. Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
• • 4. ECOG PS score of 0 or 2.
• • 5. Adequate bone marrow and organ function
• • 6. Confirmed as CLDN18.2 positive.
• Exclusion Criteria:
• • 1. Participation in another interventional study, except observational or post-intervention follow-up.
• • 2. Prior treatment with topoisomerase inhibitor-based ADC.
• • 3. 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.
• • 4. 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) .
• • 5. Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
• • 6. History of other primary malignancies, except cured or low-risk of recurrence.