A phase I/IIa study of auceliciclib in patients with advanced solid tumours and in combination with temozolomide in patients with recurrent/relapsed high-grade glioma.

ABSTRACT:

Background

This first-in-human phase I/IIa study evaluated auceliciclib, a second-generation, highly selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor with potent antitumour activity, high brain penetration, and a wide preclinical therapeutic index. The trial assessed safety, tolerability, pharmacokinetics, and preliminary efficacy of auceliciclib as monotherapy in advanced solid tumours (phase I) and in combination with temozolomide for recurrent/relapsed high-grade glioma (phase IIa).

Methods

This open-label study enrolled patients with advanced solid tumours or recurrent/relapsed high-grade glioma progressing after standard therapies. Dose escalation deployed accelerated titration followed by a 3 + 3 design. Phase I evaluated auceliciclib monotherapy (50-350 mg onc

SUBMITTER: Teo T 

PROVIDER: S-EPMC12860713 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature