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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: QLS31905; Drug: Nab-paclitaxel.; Drug: Gemcitabine; Drug: Nab-paclitaxel.; Drug: Placebo for QLS31905

• Study Type: Interventional
• Enrollment (Estimated): 602
• Phase: Phase 3

Contacts and Locations

• 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

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Lin Shen, M.D; Phone Number: 010-88196561; Email: linshenpku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.; Drug: Nab-paclitaxel.; Nab-paclitaxel will be administered as an IV infusion
Active Comparator: Placebo + nab-paclitaxel + gemcitabine (AG)	Drug: Nab-paclitaxel.; Nab-paclitaxel will be administered as an IV infusion.; Drug: Gemcitabine; Gemcitabine will be administered as an IV infusion.; Drug: Nab-paclitaxel.; Nab-paclitaxel will be administered as an IV infusion; Drug: Placebo for QLS31905; Placebo will be administered as an IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: July 13, 2025
• First Submitted That Met QC Criteria: July 13, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: QLS31905-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No