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

NCT07079228 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2025-09-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2028-12-31
Completion
2030-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079228 on ClinicalTrials.gov