A phase II study of the AKT inhibitor TAS-117 in patients with advanced solid tumors and germline PTEN mutations.

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

SUBMITTER: Rodon J 

PROVIDER: S-EPMC12804367 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature