QLS31905 plus chemotherapy versus placebo plus chemotherapy for CLDN18.2-positive advanced 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

This trial will test whether adding QLS31905 to standard chemotherapy helps adults with CLDN18.2-positive advanced pancreatic cancer respond better or live longer than chemotherapy with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07079228 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial compares QLS31905 combined with nab-paclitaxel and gemcitabine to placebo with the same chemotherapy in adults with CLDN18.2-positive unresectable locally advanced or metastatic pancreatic cancer. Eligible participants must have histologic or cytologic confirmation, measurable disease by RECIST v1.1, ECOG performance status 0–1, no prior systemic therapy for advanced disease, and adequate organ function. Participants are assigned to receive the study drug or placebo alongside standard chemotherapy and are followed for tumor response, survival outcomes, and safety measurements. The trial is conducted at Beijing Cancer Hospital and requires informed consent and regular clinic visits for treatment and monitoring.

Who should consider this trial

Good fit: Adults with confirmed CLDN18.2-positive unresectable locally advanced or metastatic pancreatic cancer who have not received prior systemic therapy for advanced disease, have ECOG 0–1, measurable disease, and adequate cardiac, liver, and renal function are ideal candidates.

Not a fit: Patients with known central nervous system metastases, active hepatitis B or C, HIV infection, recent other malignancies within five years, or recent major surgery are excluded and would not be eligible to benefit from this trial.

Why it matters

Potential benefit: If successful, adding QLS31905 to standard chemotherapy could improve tumor response rates and extend survival for patients with CLDN18.2-positive advanced pancreatic cancer.

How similar studies have performed: CLDN18.2-targeting therapies have shown promising results in other gastrointestinal cancers such as gastric cancer, but clinical evidence in pancreatic cancer is still limited.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lin Shen, M.D

Conditions Pancreatic Cancer