A Study To Compare QLS31905 And Chemotherapy With Placebo And Chemotherapy In Participants With Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: QLS31905
DRUG: Nab-paclitaxel.
DRUG: Gemcitabine
DRUG: Placebo for QLS31905
DRUG: Nab-paclitaxel.
DRUG: Gemcitabine

QLS31905-301

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-07-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-23
First Submitted that Met QC Criteria 2025-07-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-28
First Posted (ACTUAL) 2025-07-22	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: QLS31905 + nab-paclitaxel + gemcitabine (AG)	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.
ACTIVE_COMPARATOR: Placebo + nab-paclitaxel + gemcitabine (AG)	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: QLS31905 + nab-paclitaxel + gemcitabine (AG)

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.

ACTIVE_COMPARATOR: Placebo + nab-paclitaxel + gemcitabine (AG)

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.

Primary Outcome Measures	Measure Description	Time Frame
Overall Suryival(OS)	OS is defined as the time from randomization to deathdue to any cause.	Up to 48 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).	Up to 48 months
Objective Response Rate (ORR)	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1. Time Frame: Up to 48 months	Up to 48 months
Duration Of Response (DOR)	DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).	Up to 48 months
Safety assessed by Adverse Events (AEs)	An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.	Up to 48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lin Shen, M.D

Phone Number: 010-88196561

Email: linshenpku@163.com

Study Contact Backup

Name: Jihui Hao, M.D

Phone Number: 022-23340123-3070

Email: haojihui@tjmuch.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record