A phase I study of the ceramide nanoliposome in patients with advanced solid tumors.

ABSTRACT:

Purpose

Ceramide is a sphingolipid metabolite that deactivates multiple oncogenic signaling pathways and promotes cell death. In-vivo data demonstrate single-agent anti-cancer activity and enhanced efficacy with combination strategies. This phase I dose-escalation trial evaluated Ceramide nanoLiposomes (CNL) in patients with advanced solid tumors and no standard treatment option.

Methods

The primary objective was to establish the maximum tolerated dose. Secondary objectives included determining the recommended phase II dose, the safety and tolerability, the pharmacokinetic profile and preliminary anti-tumor efficacy.

Results

15 patients with heavily pretreated metastatic disease enrolled. Safety data were analyzed for all patients, while pharmacokinetic data were avai

SUBMITTER: Ciner A 

PROVIDER: S-EPMC10796569 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature