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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: QLS31905; Drug: Placebo for QLS31905; Drug: Nab-paclitaxel.; Drug: Gemcitabine

• Registration Number: NCT07079228
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Study First Posted: 2025-07-22
• Study Start: 2025-09-08
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Primary Completion: 2028-12
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 602

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLS31905 + nab-paclitaxel + gemcitabine (AG)	QLS31905	-
QLS31905 + nab-paclitaxel + gemcitabine (AG)	Nab-paclitaxel.	-
QLS31905 + nab-paclitaxel + gemcitabine (AG)	Gemcitabine	-
Placebo + nab-paclitaxel + gemcitabine (AG)	Placebo for QLS31905	-
Placebo + nab-paclitaxel + gemcitabine (AG)	Nab-paclitaxel.	-
Placebo + nab-paclitaxel + gemcitabine (AG)	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall Suryival(OS)	Up to 48 months	OS is defined as the time from randomization to deathdue to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to 48 months	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).
Objective Response Rate (ORR)	Up to 48 months	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
Duration Of Response (DOR)	Up to 48 months	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).
Safety assessed by Adverse Events (AEs)	Up to 48 months	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China