RecruitingPhase 3NCT07079228

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


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

602 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called QLS31905 combined with standard chemotherapy in people with pancreatic cancer that cannot be surgically removed or has spread to other parts of the body. The goal is to see if adding QLS31905 improves outcomes compared to chemotherapy alone. **You may be eligible if...** - You have been confirmed to have pancreatic cancer through a tissue or cell sample - Your cancer has not been treated with prior systemic (body-wide) therapy - You have at least one measurable tumor and are well enough to participate (ECOG 0–1) - Your heart, liver, and kidneys are functioning adequately - You are expected to survive at least 3 months **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have had major surgery in the past 28 days or need surgery during the study - You have cancer spread to the brain - You have hepatitis B, hepatitis C, syphilis, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLS31905

QLS31905 will be administered as an IV infusion.

DRUGNab-paclitaxel.

Nab-paclitaxel will be administered as an IV infusion.

DRUGGemcitabine

Gemcitabine will be administered as an IV infusion.

DRUGPlacebo for QLS31905

Placebo will be administered as an IV infusion.

DRUGNab-paclitaxel.

Nab-paclitaxel will be administered as an IV infusion

DRUGGemcitabine

Gemcitabine will be administered as an IV infusion.


Locations(1)

Beijing Cancer Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT07079228


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