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

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: IBI343
DRUG: Placebo

CIBI343B302

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-14
First Submitted that Met QC Criteria 2025-07-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-15
First Posted (ACTUAL) 2025-07-15	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental Arm IBI343	DRUG: IBI343 Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
PLACEBO_COMPARATOR: Control Arm Placebo	DRUG: Placebo Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental Arm

IBI343

DRUG: IBI343

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

PLACEBO_COMPARATOR: Control Arm

Placebo

DRUG: Placebo

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

Primary Outcome Measures	Measure Description	Time Frame
overall survival(OS)	Overall survival (OS) is defined as the time from randomization to death from any cause.	approximately 24 months

Secondary Outcome Measures	Measure Description	Time Frame
progression free survival(PFS)	Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.	approximately 24 months
Objective response rate (ORR)	ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) per RECIST v1.1.	approximately 24 months
disease control rate (DCR)	DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) per RECIST v1.1 criteria.	approximately 24 months
duration of response (DoR)	DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR per RECIST v1.1 criteria.	approximately 24 months
time to response (TTR)	TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.	approximately 24 months
Adverse Event	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.	approximately 24 months
Area under the plasma concentration versus time curve (AUC)	area under the curve (AUC) of single and multiple doses of IBI343	approximately 24 months
immunogenicity	anti-drug antibody and/or neutralizing antibody	approximately 24 months
maximum concentration (Cmax)	maximum concentration (Cmax) of single and multiple doses of IBI343	approximately 24 months
time to maximum concentration (Tmax)	time to maximum concentration (Tmax) of single and multiple doses of IBI343	approximately 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Penglei Zheng

Phone Number: 86-512-69566088

Email: penglei.zheng@innoventbio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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