{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Rodon J"],"funding":["NCATS NIH HHS","National Cancer Institute","NCI NIH HHS","National Institutes of Health","Taiho Oncology"],"pagination":["105932"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12804367"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["11(1)"],"pubmed_abstract":["Background
Protein kinase B (AKT)-directed therapies offer promise for patients with cancers harboring germline and somatic phosphatase and tensin homolog (PTEN) mutations. TAS-117 is an oral, selective, non-adenosine triphosphate-competitive allosteric AKT inhibitor that showed encouraging antitumor activity in a phase I study. This phase II study aimed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of TAS-117 in patients with advanced/metastatic solid tumors, including those harboring germline PTEN-inactivating mutations (EudraCT: 2020-004770-22).Materials and methods
In this open-label, multicenter, single-arm phase II study, the 3 + 3 phase I-like dose escalation lead-in part A enrolled patients with advanced/met"],"journal":["ESMO open"],"pubmed_title":["A phase II study of the AKT inhibitor TAS-117 in patients with advanced solid tumors and germline PTEN mutations."],"pmcid":["PMC12804367"],"funding_grant_id":["P30 CA008748","UL1 TR000457","K12 CA184746","R01 CA279264"],"pubmed_authors":["Chawla SP","Arkenau HT","Wacheck V","Murciano-Goroff YR","Laetsch TW","Rodon J","Funchain P","He Y","Hervieu A","Anthony K","Singer CF","Mina M","Delaloge S"],"additional_accession":[]},"is_claimable":false,"name":"A phase II study of the AKT inhibitor TAS-117 in patients with advanced solid tumors and germline PTEN mutations.","description":"Background
Protein kinase B (AKT)-directed therapies offer promise for patients with cancers harboring germline and somatic phosphatase and tensin homolog (PTEN) mutations. TAS-117 is an oral, selective, non-adenosine triphosphate-competitive allosteric AKT inhibitor that showed encouraging antitumor activity in a phase I study. This phase II study aimed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of TAS-117 in patients with advanced/metastatic solid tumors, including those harboring germline PTEN-inactivating mutations (EudraCT: 2020-004770-22).Materials and methods
In this open-label, multicenter, single-arm phase II study, the 3 + 3 phase I-like dose escalation lead-in part A enrolled patients with advanced/met","dates":{"release":"2026-01-01T00:00:00Z","publication":"2026 Jan","modification":"2026-06-16T07:29:30.881Z","creation":"2026-06-16T03:10:13.046Z"},"accession":"S-EPMC12804367","cross_references":{"pubmed":["41475241"],"doi":["10.1016/j.esmoop.2025.105932"]}}