Current Clinical Trials
Auceliciclib | AU 08
Clinical Trial of Auceliciclib in patients with advanced solid tumours – Phase I, Multi-Site, Australia (Protocol: AU08-001-01).
Lead Site: SOCRU, Bedford Park, SA, Australia
Medical Monitor: Dr Paul Wabnitz, MD, PhD, MBA, FRACP
Sponsor: Aucentra Therapeutics
Active Sites: SOCRU, Bedford Park | Sydney South West Private Hospital, Liverpool, NSW | Austin Health, Heidelberg, VIC
Status: Actively Recruiting
Clinical Trial Update | 24.02.2022
Aucentra Therapeutics is pleased to announce that it has received regulatory approval to progress to a Phase 1a/b clinical trial of Auceliciclib (AU3-14) in combination with Temozolomide for recurrent/refractory GBM patients. To read more, click here.
Clinical Trial Update | 28.09.2022
Aucentra Therapeutics is pleased to announce that it has received regulatory approval to progress to a phase 1/2 trial for Auceliciclib in combination with Temozolomide for recurrent/refractory Glioblastoma multiforme (GBM) patients. As of the 28th of September 2022, patients have been dosed with Auceliciclib, and dosing has completed for Cohorts 1 – 5 of the monotherapy dose escalation, and Cohorts 1a, 1b for the combination therapy arms with Temozolomide (TMZ). To date, all cohorts of Auceliciclib have been well tolerated with no dose limiting toxicities observed to date even at the highest dose level. Additionally, no drug related serious adverse events have been observed.
Based on these encouraging findings, Aucentra have further amended the study protocol in light of the recent pharmacology findings to now include twice daily dosing of Auceliciclib for 28 days of each treatment cycle for monotherapy and combination dose escalation arms. This combination therapy escalation arm will then expand at the recommended Phase 2 dose level and further evaluate the potential efficacy of Auceliciclib in improving patient outcomes for this difficult to treat disease. This clinical trial has been designed specifically to provide an alternative treatment option for GBM patients where there is a large unmet need due to limited treatment options for this aggressive disease.
For more information, please refer: https://www.anzctr.org.au/ACTRN12621000479808.aspx