Actively Recruiting
A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-08-15
201
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with study visits and procedures
- Histologically confirmed unresectable locally advanced or metastatic pancreatic cancer
- Progression after at least two systemic therapies, including fluorouracil-based and gemcitabine-based treatments
- ECOG performance status score of 0 or 2
- Adequate bone marrow and organ function
- Confirmed Claudin 18.2 positive tumor status
You will not qualify if you...
- Participation in another interventional study (observational or post-intervention follow-up allowed)
- Prior treatment with topoisomerase inhibitor-based antibody-drug conjugate (ADC)
- Received last dose of anti-cancer therapy within 2 weeks or 5 half-lives before study treatment
- Planned receipt of other anti-tumor treatments during study drug administration (except palliative radiotherapy for symptom relief)
- Symptomatic central nervous system metastasis; asymptomatic brain metastases allowed under specific criteria
- History of other primary malignancies except cured or low-risk recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
Research Team
P
Penglei Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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