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NCT Number: NCT07079228

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QLS31905

Drug

QLS31905 will be administered as an IV infusion.

Nab-paclitaxel.

Drug

Nab-paclitaxel will be administered as an IV infusion.

Gemcitabine

Drug

Gemcitabine will be administered as an IV infusion.

Placebo for QLS31905

Drug

Placebo will be administered as an IV infusion.

Primary outcomes

  1. Overall Suryival(OS)

    Time frame: Up to 48 months

    OS is defined as the time from randomization to deathdue to any cause.

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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).

  2. Objective Response Rate (ORR)

    Time frame: 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

  3. Duration Of Response (DOR)

    Time frame: 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).

  4. Safety assessed by Adverse Events (AEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jihui Hao, M.D

CONTACT

[email protected]

022-23340123-3070

Lin Shen, M.D

CONTACT

[email protected]

010-88196561

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jul 22, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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