Health AI Central
Peer-Reviewed Publication
Nat Commun2026;17(1)October 9, 2026Journal Article

The conformation-selective PI3Kδ inhibitor roginolisib in patients with advanced or metastatic cancer, including metastatic uveal melanoma: first-in-human clinical trial.

Anna Maria Di Giacomo1,2, Matteo Simonelli3, Agnese Losurdo3, Pavlina Spiliopoulou4, Vincenzo D'Alonzo1, Giovanni Amato1, Monica Valente1, Hugo Barcenilla5, Anette Johnsson5, Laura Gonzalez5, Ziyang Tan5, Lakshmikanth Tadepally5,6,7, Petter Brodin5,6,7, Michael Lahn8, Giusy Di Conza8, Rebeca Zorrilla8, Lars van der Veen8, Alessio Bevilacqua8, Paramjit Kaur8, Tracey Hammett8, Marco Durini9, Andrea Corsi10, Nikhil Sindhwani10, Mariaelena Occhipinti11, Robert Snijder12, Ayad Abdul-Ahad12, Aniko Meijer13, Umberto Postiglione13, Gregory Price14, Gillian Hopton15, Emily Wood15, Vincent Vuaroqueaux16, Anne-Lise Peille16, Jill Graham4, Ming Poi17, David Spetzler17, Carmelo Carlo-Stella3, Armando Santoro3, Thomas R Jeffry Evans18, Michele Maio19,20
1Center for Immuno-Oncology, University Hospital of Siena, University of Siena, Siena, Italy.
2Italian Network for Cancer Biotherapy and Immunotherapy (Network Italiano per la Bioterapia e l'Immunoterapia dei Tumori (NIBIT) Foundation ETS, Genova, Italy.
3Istituto di Ricovero e Cura a Carattere Scientifico Humanitas Research Hospital, Rozzano (Milan), Italy.
4School of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
5Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.
6Department of Immunology and Inflammation, Imperial College London, London, UK.
7Medical Research Council London Institute of Medical Sciences (LMS), Imperial College London, London, UK.
8iOnctura SA, Geneva, Switzerland.
9Fortrea, Milano, Italy.
10Radiomics.bio, Liège, Belgium.
11Department of Radiology, San Cataldo Hospital, Fondazione Toscana Gabriele Monasterio-National Research Council, Pisa, Italy.
12BOTh Analytics GmbH, Munich, Germany.
13BioLizard NV, Ghent, Belgium.
14Indiana University Health Simon Cancer Center, Indianapolis, IN, USA.
15Veramed Ltd., Regal House, Twickenham, United Kingdom.
164HF Biotec GmbH, Freiburg, Germany.
17Caris Life Sciences, Phoenix, AZ, USA.
18School of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom. j.evans@crukscotlandinstitute.ac.uk.
19Center for Immuno-Oncology, University Hospital of Siena, University of Siena, Siena, Italy. maio@unisi.it.
20Italian Network for Cancer Biotherapy and Immunotherapy (Network Italiano per la Bioterapia e l'Immunoterapia dei Tumori (NIBIT) Foundation ETS, Genova, Italy. maio@unisi.it.
PubMed DOI

Abstract

Phosphatidylinositol 3-kinase delta (PI3Kδ) promotes tumour cell growth directly or indirectly by activating immune-suppressive cells. In contrast to previous PI3Kδ inhibitors, roginolisib is a selective, non-ATP competitive inhibitor, which locks PI3Kδ into an inactive state and causes an allosteric modulation. In a First-in-Human dose study, continuous daily dosing of roginolisib was investigate…

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