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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: IBI343; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 201
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Penglei Zheng; Phone Number: 86-512-69566088; Email: penglei.zheng@innoventbio.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201321
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xianjun Yu; Phone Number: 86-21-64175590; Email: yuxianjun@fudanpci.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 26, 2025
• First Submitted That Met QC Criteria: July 4, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CIBI343B302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No