TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors

Summary

TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Particle features including size, charge distribution, lipid composition and drug release add up to a considerably altered particle behavior compared to Caelyx®, potentially explaining the lack of hand-foot-syndrome in respective animal models. Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of doxorubicin with promising activity and good tolerability.

Timeline

Start

2018-11-12

Primary completion

2023-09-22

Completion

2023-12-22

Outcome

Outcome not reported

Stopped (Enrollment): “The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.”

Publications

• Klose M, Colombo I, Gobat K, Koster KL, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Zurrer-Hardi U, Eckhardt K, Hayoz S, Halbherr S, Sessa C, Michelet R, Mc Laughlin AM, Hess D, Stathis A, Kloft C, Joerger M. TLD-1, a Novel Liposomal Doxorubicin, in Patients with Solid Tumors: Comparative Pharmacokinetics and Final Results of a Multicenter Phase 1 Study (SAKK 65/16). Clin Pharmacokinet. 2026 Feb;65(2):217-228. doi: 10.1007/s40262-025-01588-z. Epub 2025 Nov 18.
• Mc Laughlin AM, Hess D, Michelet R, Colombo I, Haefliger S, Bastian S, Rabaglio M, Schwitter M, Fischer S, Eckhardt K, Hayoz S, Kopp C, Klose M, Sessa C, Stathis A, Halbherr S, Huisinga W, Joerger M, Kloft C. Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial. Cancer Chemother Pharmacol. 2024 Sep;94(3):349-360. doi: 10.1007/s00280-024-04679-z. Epub 2024 Jun 15.
• Colombo I, Koster KL, Holer L, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Eckhardt K, Hayoz S, Mc Laughlin AM, Kloft C, Klose M, Halbherr S, Baumgartner C, Sessa C, Stathis A, Hess D, Joerger M. TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: Dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16). Eur J Cancer. 2024 Apr;201:113588. doi: 10.1016/j.ejca.2024.113588. Epub 2024 Feb 2.

Drugs

Indications