NCT07314385

NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer

A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.

Detailed description

With dose escalation under the 3+3 phase I design, NH002-based sonoporation will be performed in 4 cohorts. In cohort 1, NH002 will be given with one short course of sonoporation (on Cycle 1 Day 1). In cohort 2, NH002 will be given with one long course of sonoporation (on Cycle 1 Day 1). In cohort 3, NH002 will be given with two long courses of sonoporation (on Cycle 1 Day 1 and Day 2). In cohort 4, NH002 will be given with three long courses of sonoporation (on Cycle 1 Days 1, 2, and 3). During the NH002-based sonoporation, chemotherapy with standard dose of nanoliposomal irinotecan plus 5-FU and leucovorin will be administered concomitantly. The primary endpoint is safety parameters and to determine the dose-limiting toxicity and maximum tolerated dose.

Conditions

• Pancreatic Adenocarcinoma Metastatic
• Liver Metastasis

Interventions

Type	Name	Description
DRUG	nanoliposomal irinotecan+5-FU+leucovorin	nanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2
DRUG	NH002 (Perflutren Lipid Microspheres) Injectable Suspension	2.5 microliter per kilogram (body weight) per dose
DEVICE	Aco Apache Ultrasound	echo for sonoporation

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: Taiwan