NCT06632574

A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of Paclitaxel Cationic Liposome for Injection in the Treatment of Patients With Advanced Solid Tumors Via Transcatheter Arterial Infusion Therapy.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.

Detailed description

This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of paclitaxel cationic liposomes for injection administered via transcatheter arterial infusion in the treatment of advanced solid tumors. Paclitaxel cationic liposomes will be administered via arterial infusion on the first day of each cycle, with each treatment cycle lasting 3 weeks. Eligible participants will receive 4-6 cycles of study treatment. Treatment may be terminated early in the event of the following: disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or any other circumstances meeting the criteria for treatment discontinuation (whichever occurs first).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	paclitaxel cationic liposomes	Paclitaxel cationic liposomes is a modified new drug. In this study, administration is performed through arterial catheter infusion.

Timeline

• Start date: 2014-03-19
• Primary completion: 2025-10-31
• Completion: 2027-03-31
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: China