NCT07079228

A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	QLS31905	QLS31905 will be administered as an IV infusion.
DRUG	Nab-paclitaxel.	Nab-paclitaxel will be administered as an IV infusion.
DRUG	Gemcitabine	Gemcitabine will be administered as an IV infusion.
DRUG	Placebo for QLS31905	Placebo will be administered as an IV infusion.
DRUG	Nab-paclitaxel.	Nab-paclitaxel will be administered as an IV infusion
DRUG	Gemcitabine	Gemcitabine will be administered as an IV infusion.

Timeline

• Start date: 2025-09-08
• Primary completion: 2028-12-01
• Completion: 2030-09-01
• First posted: 2025-07-22
• Last updated: 2025-09-23

Locations

1 site across 1 country: China