Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07079228
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Beijing Cancer Hospital

Beijing, China