Klose, Marian https://orcid.org/0009-0005-1706-6289
Colombo, Ilaria https://orcid.org/0000-0002-0602-8667
Gobat, Katrin
Koster, Kira-Lee https://orcid.org/0000-0002-6549-8124
Haefliger, Simon https://orcid.org/0000-0002-9721-3314
Rabaglio, Manuela https://orcid.org/0000-0002-6764-1844
Bastian, Sara
Schwitter, Michael
Zürrer-Härdi, Ursina
Eckhardt, Katrin
Hayoz, Stefanie https://orcid.org/0000-0002-2265-6559
Halbherr, Stefan https://orcid.org/0009-0007-3641-6795
Sessa, Cristiana
Michelet, Robin https://orcid.org/0000-0002-5485-607X
Mc Laughlin, Anna M. https://orcid.org/0000-0002-5936-1877
Hess, Dagmar https://orcid.org/0009-0007-4993-8744
Stathis, Anastasios https://orcid.org/0000-0002-2859-7529
Kloft, Charlotte
Joerger, Markus https://orcid.org/0000-0001-6602-6287
Clinical trials referenced in this document:
Documents that mention this clinical trial
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)
https://doi.org/10.1007/s40262-025-01588-z
Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial
https://doi.org/10.1007/s00280-024-04679-z
Article History
Received: 15 June 2025
Accepted: 8 October 2025
First Online: 18 November 2025
Declarations
:
: Ilaria Colombo: declares institutional funding for clinical trials as PI from AstraZeneca, Merck Sharp & Dhome, Vivesto, Tolremo, Orion, Bayer, lncyte, Debio; consultancy/advisor role from AstraZeneca, GlaxoSmithKline, Merck Sharp & Dhome, AbbVie, Biontech, lncyte, Beigene outside the submitted work; Kira-Lee Koster: support for attending meetings and travel (paid to institution) from Takeda Pharma and Janssen-Cilag; Anna M. Mc Laughlin: current employee of Pharmetheus AB and a paid consultant to multiple pharmaceutical companies; Stefan Halbherr: Stefan Halbherr owns shares of InnoMedica Holding AG and functions as part of the executive management of the firm; Anastasios Stathis: Institutional funding for clinical trials: Innomedica, Abbvie; ADC Therapeutics; Amgen, Astra Zeneca; Bayer; Cellestia; Incyte, Loxo Oncology; Merck MSD; Novartis; Pfizer; Philogen; Roche. Consultant/expert testimony/advisory board (institutional): Debiopharm, Janssen, AstraZeneca, Incyte, Eli Lilly, Novartis, Roche, Loxo Oncology. Travel grant: Incyte; Astra Zeneca. Charlotte Kloft: research grants from an industry consortium (AbbVie Deutschland GmbH & Co. K.G., AstraZeneca, Boehringer Ingelheim Pharma GmbH & Co. KG., Gruenenthal GmbH, F. Hoffmann- La Roche Ltd., Merck KGaA, Novo Nordisk A/S and Sanofi) for the graduate research training program PharMetrX, from the Innovative Medicines Initiative-Joint Undertaking (“DDMoRe”), from H2020- EU.3.1.3 (“FAIR”), Diurnal Ltd. and the Federal Ministry of Education and Research within the Joint Programming Initiative on Antimicrobial Resistance Initiative (“JPIAMR”), all outside the submitted work; Markus Joerger: advisory role (institutional): Novartis, Astra Zeneca, Basilea Pharmaceutica, Bayer, BMS, Debiopharm, MSD, Roche, Sanofi; research funding: Swiss Cancer Research; travel grants: Roche, Sanofi, Takeda. All other authors declare no competing interests for this work.
: Conceptualization: Marian Klose, Ilaria Colombo, Katrin Gobat, Kira-Lee Koster, Simon Haefliger, Manuela Rabaglio, Sara Bastian, Michael Schwitter, Ursina Zürrer-Härdi, Katrin Eckhardt, Stefanie Hayoz, Stefan Halbherr, Cristiana Sessa, Robin Michelet, Anna M. Mc Laughlin, Dagmar Hess, Anastasios Stathis, Charlotte Kloft, Markus Joerger; data curation: Marian Klose, Ilaria Colombo, Katrin Gobat, Kira-Lee Koster, Simon Haefliger, Manuela Rabaglio, Sara Bastian, Michael Schwitter, Ursina Zürrer-Härdi, Katrin Eckhardt, Cristiana Sessa, Robin Michelet, Anna M. Mc Laughlin, Dagmar Hess, Anastasios Stathis, Charlotte Kloft, Markus Joerger; formal analysis: Marian Klose, Ilaria Colombo, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Robin Michelet, Anna M. Mc Laughlin, Charlotte Kloft, Markus Joerger; funding acquisition: Stefan Halbherr; investigation: Ilaria Colombo, Kira-Lee Koster, Simon Haefliger, Manuela Rabaglio, Sara Bastian, Michael Schwitter, Ursina Zürrer-Härdi, Cristiana Sessa, Dagmar Hess, Anastasios Stathis, Markus Joerger; methodology: Marian Klose, Ilaria Colombo, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Robin Michelet, Anna M. Mc Laughlin, Anastasios Stathis, Charlotte Kloft, Markus Joerger; project administration: Marian Klose, Ilaria Colombo, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Dagmar Hess, Anastasios Stathis, Charlotte Kloft, Markus Joerger; resources: Stefan Halbherr; software: Marian Klose, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Robin Michelet, Anna M. Mc Laughlin, Charlotte Kloft, Markus Joerger; supervision: Katrin Eckhardt, Dagmar Hess, Charlotte Kloft, Markus Joerger; validation: Marian Klose, Ilaria Colombo, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Robin Michelet, Anna M. Mc Laughlin, Markus Joerger; visualization: Marian Klose, Ilaria Colombo, Katrin Gobat, Katrin Eckhardt, Stefanie Hayoz, Robin Michelet, Anna M. Mc Laughlin, Charlotte Kloft, Markus Joerger; writing – original draft: Marian Klose, Ilaria Colombo, Katrin Gobat, Markus Joerger; writing – review & editing: Marian Klose, Ilaria Colombo, Katrin Gobat, Kira-Lee Koster, Simon Haefliger, Manuela Rabaglio, Sara Bastian, Michael Schwitter, Ursina Zürrer-Härdi, Katrin Eckhardt, Stefanie Hayoz, Stefan Halbherr, Cristiana Sessa, Robin Michelet, Anna M. Mc Laughlin, Dagmar Hess, Anastasios Stathis, Charlotte Kloft, Markus Joerger.
: The study was approved by the ethics committees of the participating institutions (lead ethics committee: Ethikkommission Ostschweiz; also: Kantonale Ethikkommission Bern, Ethikkommission Nordwest- und Zentralschweiz, Ethikkommission Tessin, and Ethikkommission Zürich), and by the relevant regulatory authorities (Swissmedic). All participants provided written informed consent prior to inclusion in the study. The study was conducted in accordance with the ethical standards laid down in the Declaration of Helsinki, as well as in compliance with Good Clinical Practice guidelines.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: The data of this study can be obtained from the corresponding author upon reasonable request.
: The source code supporting theresults of this study can be made available upon reasonable request.