Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study.

Humans Female Glioblastoma Neoplasm Recurrence, Local / drug therapy Ovarian Neoplasms / drug therapy
Avanbulin BAL101553 Glioblastoma Lisavanbulin Microtubule-targeting agent

Journal

Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330

Informations de publication

Date de publication:
04 2023
Historique:
received: 23 12 2022
accepted: 31 01 2023
medline: 1 5 2023
pubmed: 16 2 2023
entrez: 15 2 2023
Statut: ppublish

Résumé

Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862), a microtubule-destabilizing agent. The goal of this study (NCT02895360) was to characterize the safety, tolerability and antitumor activity of lisavanbulin administered as a 48-hour intravenous (IV) infusion at the recommended Phase 2 dose (RP2D) of 70 mg/m

Identifiants

DOI: 10.1007/s10637-023-01336-9 PMID: 36792805 PMC: PMC10140113
pubmed: 36792805
doi: 10.1007/s10637-023-01336-9
pii: 10.1007/s10637-023-01336-9
pmc: PMC10140113
doi:

Substances chimiques

lisavanbulin 0

Banques de données

ClinicalTrials.gov
['NCT02895360']

Types de publication

Multicenter Study Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

267-275

Informations de copyright

© 2023. The Author(s).

Références

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Pohlmann J, Bachmann F, Schmitt-Hoffmann A et al (2011) Abstract 1347: BAL101553: an optimized prodrug of the microtubule destabilizer BAL27862 with superior antitumor activity. Cancer Res 71:1347. https://doi.org/10.1158/1538-7445.AM2011-1347
doi: 10.1158/1538-7445.AM2011-1347
Prota AE, Danel F, Bachmann F et al (2014) The novel microtubule-destabilizing drug BAL27862 binds to the colchicine site of tubulin with distinct effects on microtubule organization. J Mol Biol 426:1848–1860. https://doi.org/10.1016/J.JMB.2014.02.005
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Bachmann F, Burger K, Lane H (2015) Abstract 3789: BAL101553 (prodrug of BAL27862): the spindle assembly checkpoint is required for anticancer activity. Cancer Res 75:3789. https://doi.org/10.1158/1538-7445.AM2015-3789
doi: 10.1158/1538-7445.AM2015-3789
Sharma A, Bachmann F, Broggini-Tenzer A et al (2017) The novel tubulin-binding, tumor checkpoint controller BAL101553 has differential effects on tumor vascularization with IV and oral dosing and provides superior anti-tumor activity in combination with bevacizumab. Cancer Res 77. https://doi.org/10.1158/1538-7445.AM2017-LB-151 . LB-151-LB-151
Bachmann F, Lane H (2012) 421 dual mechanism of action of the Novel Microtubule-targeting drug BAL27862 (active Moiety of the Prodrug BAL101553): targeting Tumor and Vascular cells. Eur J Cancer 48:128. https://doi.org/10.1016/S0959-8049(12)72219-0
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Bachmann F, Burger K, Duran GE et al (2014) Abstract 831: BAL101553 (prodrug of BAL27862): a unique microtubule destabilizer active against drug refractory breast cancers alone and in combination with trastuzumab. Cancer Res 74:831. https://doi.org/10.1158/1538-7445.AM2014-831
doi: 10.1158/1538-7445.AM2014-831
Duran GE, Lane H, Bachmann F, Sikic BI (2010) In vitro activity of the novel tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer variants selected for resistance to taxanes. Cancer Res 70. https://doi.org/10.1158/1538-7445.AM10-4412
Esteve M-A, Honore S, Mckay N et al (2010) Abstract 1977: BAL27862: a unique microtubule-targeted drug that suppresses microtubule dynamics, severs microtubules, and overcomes Bcl-2- and tubulin subtype-related drug resistance. Cancer Res. https://doi.org/10.1158/1538-7445.AM10-1977 . 70:1977
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Sharma A, Broggini-Tenzer A, Vuong V et al (2017) The novel microtubule targeting agent BAL101553 in combination with radiotherapy in treatment-refractory tumor models. Radiother Oncol 124:433–438. https://doi.org/10.1016/j.radonc.2017.07.024
doi: 10.1016/j.radonc.2017.07.024 pubmed: 28797699
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doi: 10.1007/s10637-019-00850-z
Tiu C, Tzankov A, Plummer R et al (2020) 382P the potential utility of end-binding protein 1 (EB1) as response-predictive biomarker for lisavanbulin: final results from a phase I study of lisavanbulin (BAL101553) in adult patients with recurrent glioblastoma (GBM). Ann Oncol 31:S404. https://doi.org/10.1016/J.ANNONC.2020.08.491
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Tiu CD, Derby S, Haris NM et al (2021) The potential utility of end-binding protein 1 (EB1) as response-predictive biomarker for lisavanbulin: a phase 2 study of lisavanbulin (BAL101553) in adult patients with recurrent glioblastoma. J Clin Oncol 39:TPS2068–TPS2068. https://doi.org/10.1200/JCO.2021.39.15_suppl.TPS2068
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Auteurs

Markus Joerger (M)

Department of Hematology/Oncology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Swiss Group for Clinical Cancer Research, Bern, Switzerland.

Thomas Hundsberger (T)

Department of Hematology/Oncology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.

Simon Haefliger (S)

Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Roger von Moos (R)

Department of Medical Oncology/Hematology, Cantonal Hospital Graubünden, Chur, Switzerland.

Andreas F Hottinger (AF)

Lundin Family Brain Tumor Research Center, Departments of Oncology & Clinical Neurosciences, Lausanne University Hospital & University of Lausanne, Lausanne, Switzerland.

Thomas Kaindl (T)

Basilea Pharmaceutica International Ltd, Hegenheimermattweg 167b, Allschwil, 4123, Switzerland. Thomas.Kaindl@basilea.com.

Marc Engelhardt (M)

Basilea Pharmaceutica International Ltd, Hegenheimermattweg 167b, Allschwil, 4123, Switzerland.

Michalina Marszewska (M)

Basilea Pharmaceutica International Ltd, Hegenheimermattweg 167b, Allschwil, 4123, Switzerland.

Heidi Lane (H)

Basilea Pharmaceutica International Ltd, Hegenheimermattweg 167b, Allschwil, 4123, Switzerland.

Patrick Roth (P)

Department of Neurology and Brain Tumor Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.

Anastasios Stathis (A)

Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Safety and anti-tumor activity of lisavanbulin...
questionsmedicales.fr › Tumeurs › Tumeurs par type histologique › Tumeurs du tissu nerveux › Tumeurs neuroectodermiques › Tumeurs neuroépitheliales › Gliome › Astrocytome › Glioblastome › Safety and anti-tumor activity of lisavanbulin...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Processus néoplasiques › Récidive tumorale locale › Safety and anti-tumor activity of lisavanbulin...
questionsmedicales.fr › Maladies endocriniennes › Troubles gonadiques › Maladies ovariennes › Tumeurs de l'ovaire › Safety and anti-tumor activity of lisavanbulin...