auceliciclib (AU3-14) / Aucentra, Qianhong Bio-Pharma - LARVOL DELTA

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. (PubMed, ESMO Open) - "Auceliciclib was well tolerated, and demonstrated dose-dependent pharmacokinetics and preliminary clinical activity in heavily pretreated patients. Recommended phase II doses are 500 mg twice daily (monotherapy) and 300 mg twice daily with 100 mg temozolomide once daily (combination therapy). These findings support further clinical development of auceliciclib for high-grade glioma and other malignancies."

First-in-human • Journal • P1/2 data • Brain Cancer • Fatigue • Glioma • High Grade Glioma • Oncology • Solid Tumor

A brain-penetrant CDK4/6 inhibitor - AU3-14 shows robust anti-tumor efficacy against glioblastoma. (PubMed, Biomed Pharmacother) - P1/2 | "Despite extensive research, advances in GBM treatment have seen limited progress, with current therapy largely reliant on temozolomide (TMZ), underscoring the need for novel therapeutic strategies...More extensive pharmacokinetic studies revealed that AU3-14 efficiently crosses the blood-brain barrier, with an unbound brain-to-plasma concentration ratios (Kp,uu) of 1.2 and 0.63 at single oral doses of 10 and 30 mg/kg, respectively, which were 2-4 times higher than those of abemaciclib...Moreover, AU3-14 enhances TMZ's anti-tumor efficacy and delays the onset of TMZ resistance. These findings support the clinical phase I/IIa investigation of AU3-14 for the treatment of GBM (ACTRN12621000479808)."

Journal • Brain Cancer • Glioblastoma • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CDKN2A

An interventional study to safety, tolerability (how well a substance is tolerated by patients), and Pharmacokinetics (PK, the measure of how the human body processes a substance) of different dosages of Auceliciclib when given to patients with advanced solid tumours as either the only treatment, or in patients with a specific type of cancer, Glioblastoma multiforme (GBM), when given together... (ANZCTR) - P1/2 | N=60 | Completed | Sponsor: Aucentra Therapeutics Pty Ltd. | Active, not recruiting ➔ Completed

Trial completion • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

An interventional study to safety, tolerability (how well a substance is tolerated by patients), and Pharmacokinetics (PK, the measure of how the human body processes a substance) of different dosages of Auceliciclib when given to patients with advanced solid tumours as either the only treatment, or in patients with a specific type of cancer, Glioblastoma multiforme (GBM), when given together... (ANZCTR) - P1/2 | N=60 | Active, not recruiting | Sponsor: Aucentra Therapeutics Pty Ltd. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor