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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: QLS31905; Drug: Nab-paclitaxel.; Drug: Placebo for QLS31905

Study type: Interventional

Funder types: Industry

Identifiers

NCT07079228

QLS31905-301

Details and patient eligibility

About

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.

Enrollment: 602 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

602 participants in 2 patient groups

QLS31905 + nab-paclitaxel + gemcitabine (AG)

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel.

Drug: QLS31905

Drug: Nab-paclitaxel.

Drug: Gemcitabine

Placebo + nab-paclitaxel + gemcitabine (AG)

Active Comparator group

Treatment:

Drug: Gemcitabine

Drug: Placebo for QLS31905

Drug: Nab-paclitaxel.

Drug: Nab-paclitaxel.

Drug: Gemcitabine