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A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07079228•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily participate in the study and sign the informed consent form;
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
•Expected survival time ≥ 3 months;
•Histologically or cytologically confirmed diagnosis of pancreatic cancer;
•No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
•At least one measurable lesion per RECIST v1.1;
•Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria

•History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
•Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
•Known central nervous system metastases;
•Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
•Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.

Locations (1)

Beijing Cancer Hospital

Beijing, China

Key Dates

Start Date

September 8, 2025

Primary Completion Date

December 1, 2028

Completion Date

September 1, 2030

Last Updated

September 23, 2025

Enrollment

602

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

QLS31905

DRUG

Nab-paclitaxel.

DRUG

Gemcitabine

DRUG

Placebo for QLS31905

DRUG

Nab-paclitaxel.

DRUG

Gemcitabine

DRUG

Contacts

Lin Shen, M.D

CONTACT

010-88196561 linshenpku@163.com

Jihui Hao, M.D

CONTACT

022-23340123-3070 haojihui@tjmuch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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