Actively Recruiting
A Multicenter, Randomized, Double-Blind Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Claudin 18.2-Positive, Locally Advanced or Metastatic Pancreatic Cancer After at Least Two Prior Therapies
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-08-15
201
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IBI343 monotherapy combined with best supportive care in people with Claudin 18.2-positive locally advanced unresectable or metastatic pancreatic cancer who have already tried at least two prior treatments. This study is a multicenter, randomized, double-blind, phase III trial aiming to compare overall survival between those receiving IBI343 plus best supportive care and those receiving placebo plus best supportive care. Participants will be randomly assigned in a 2:1 ratio to receive either IBI343 or placebo. Both treatments are given as a 6 mg/kg intravenous infusion on day 1 of a 3-week cycle. The study plans to enroll approximately 201 participants who will continue to receive best supportive care alongside the assigned study treatment. Throughout the study, participants will be monitored for about 24 months to assess overall survival as the primary outcome. Secondary measures include progression-free survival, response rates, duration and timing of response, adverse events, and drug concentration levels in the blood. Researchers will also evaluate immunogenicity and other pharmacokinetic parameters. Safety and treatment effects will be closely followed during regular visits and assessments.
CONDITIONS
Brief 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...
- Sign the written informed consent form and agree to comply with study visits and procedures
- Have histologically confirmed unresectable locally advanced or metastatic pancreatic cancer
- Have received at least two prior systemic therapies including fluorouracil-based and gemcitabine-based treatments with disease progression
- Have an ECOG performance status score of 0 or 2
- Have adequate bone marrow and organ function
- Confirmed positive for Claudin 18.2
You will not qualify if you...
- Currently participating in another interventional study (except observational or post-intervention follow-up)
- Prior treatment with topoisomerase inhibitor-based antibody-drug conjugates
- Received anti-cancer therapy within 2 weeks or 5 half-lives before the first study dose
- Plan to receive other anti-tumor treatments during the study (except palliative radiotherapy for symptom relief)
- Have symptomatic central nervous system metastasis; asymptomatic brain metastases allowed under specific criteria
- History of other primary cancers except those cured or with low risk of recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 24 months
Participants receive IBI343 or placebo by intravenous infusion every 3 weeks in combination with best supportive care.
Infusions every 3 weeks
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
Research Team
P
Penglei Zheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here