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A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine \[AG\]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
Official title: A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
602
Start Date
2025-09-08
Completion Date
2030-09
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
QLS31905
QLS31905 will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion.
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Placebo for QLS31905
Placebo will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Locations (1)
Beijing Cancer Hospital
Beijing, China