Trial reportESMO open2026
A phase II study of the AKT inhibitor TAS-117 in patients with advanced solid tumors and germline PTEN mutations.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundProtein 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
methodsIn 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/metastatic solid tumors irrespective of gene alterations (all-comers). Patients received TAS-117 once daily (o.d.) or intermittent dosing (ID) regimens (4 days on/3 days off), with a 16-mg/day o.d. or 24-mg/day ID starting dose. The primary objective was safety and to define maximum tolerated dose/recommended phase II dose (RP2D). The dose/regimen confirmation part B was to further assess RP2D in patients harboring germline PTEN mutations.
resultsOverall, 17 patients were enrolled in part A (all-comers n = 16, dose and regimen confirmation, n = 1). Dose-limiting toxicities were observed in three patients [febrile neutropenia at 20 mg o.d. (n = 1); grade 3 oral mucositis at 28 mg ID (n = 2)]. Most common treatment-related adverse events (AEs) (all grade/grade ≥3) were rash (58.8%/17.6%), fatigue (35.3%/1%), pruritus (29.4%/0%), hyperglycemia (29.4%/1%), and decreased appetite (17.6%/0%). RP2D was determined to be 16 mg/kg o.d. Seven patients had stable disease. One of two patients with a germline PTEN mutation (metaplastic breast cancer) had stable disease ongoing for 19.1 months as of the data cut-off. The study was closed due to enrollment challenges in the germline PTEN mutation carrier population.
conclusionsTAS-117 at the RP2D of 16 mg o.d. was tolerable, with a manageable safety profile. Clinical benefit, although durable, was only observed in a single patient with a germline PTEN mutation.
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