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

RECRUITINGPHASE3

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

NCT07066098•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Detailed 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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 4, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2028

Last Updated

August 15, 2025

Enrollment

201

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

IBI343

DRUG

Placebo

DRUG

Contacts

Penglei Zheng

CONTACT

86-512-69566088 penglei.zheng@innoventbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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