A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)
NCT ID: NCT07066098
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
201 participants
INTERVENTIONAL
2025-08-04
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Arm
IBI343
IBI343
Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Control Arm
Placebo
Placebo
Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Interventions
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IBI343
Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Placebo
Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI343B302
Identifier Type: -
Identifier Source: org_study_id
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