EndoTAG-1 (paclitaxel liposomal)

P3, N=420, Suspended, SynCore Biotechnology Co., Ltd. | Trial completion date: Jun 2024 --> Jun 2027 | Trial primary completion date: Mar 2023 --> Mar 2025

Carriers based on cationic liposomes (CLs) with fluid (i.e., chain-melted) membranes (e.g., EndoTAG-1) have shown promise in preclinical and late-stage clinical studies...At 5 and 10 mol % of a PEG-lipid (PEG5K-lipid, molecular weight of PEG 5000 g/mol), the mixture of PEGylated CLs and nanodiscs was able to incorporate up to 2.5 mol % PTX without crystallization for at least 20 h. Remarkably, compared to preparations containing 2 and 5 mol % PEG5K-lipid (with the PEG chains in the mushroom regime), the particles at 10 mol % (with PEG chains in the brush regime) showed significantly higher blood half-life, tumor penetration, and proapoptotic activity. Our study suggests that increasing the PEG coverage of CL-based drug nanoformulations can improve their pharmacokinetics and therapeutic efficacy.

P3, N=420, Suspended, SynCore Biotechnology Co., Ltd. | Recruiting --> Suspended

Aim: To investigate the toxicity of nab-paclitaxel (wNP)/nonpegylated liposome-encapsulated doxorubicin (wNPLD) combination in HER2-negative metastatic breast cancer (MBC) patients as first-line treatment. The objective response rate was 68% (response mean duration: 12.6 months). wNP/wNPLD combination constitutes an active regimen with mild toxicity.