RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd. • ClinicalTrials.gov ID: NCT07066098

Registry updated: 2026-10-05

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Description

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.

Interventions

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

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.

Conditions

Pancreatic Cancer

Locations

Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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