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Recruiting NCT07066098

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

Phase III Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI343, Placebo.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • overall survival(OS) [Time frame: approximately 24 months]
Secondary outcome measures (10)
  • progression free survival(PFS) [Time frame: approximately 24 months]
  • Objective response rate (ORR) [Time frame: approximately 24 months]
  • disease control rate (DCR) [Time frame: approximately 24 months]
  • duration of response (DoR) [Time frame: approximately 24 months]
  • time to response (TTR) [Time frame: approximately 24 months]
  • Adverse Event [Time frame: approximately 24 months]
  • Area under the plasma concentration versus time curve (AUC) [Time frame: approximately 24 months]
  • immunogenicity [Time frame: approximately 24 months]
  • maximum concentration (Cmax) [Time frame: approximately 24 months]
  • time to maximum concentration (Tmax) [Time frame: approximately 24 months]

Eligibility criteria

Inclusion criteria

  • Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
  • Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
  • Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
  • ECOG PS score of 0 or 2.
  • Adequate bone marrow and organ function
  • Confirmed as CLDN18.2 positive.

Exclusion criteria

  • Participation in another interventional study, except observational or post-intervention follow-up.
  • Prior treatment with topoisomerase inhibitor-based ADC.
  • 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.
  • 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) .
  • Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria.
  • History of other primary malignancies, except cured or low-risk of recurrence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07066098 · CIBI343B302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗