ATTACK-1 trial

A clinical trial combining a Phase 1 study of auceliciclib in patients with advanced solid tumours and a Phase 2a study in combination with TMZ in recurrent/refractory GBM patients (Protocol: AU08-001-01)

Active Sites:
SOCRU, Bedford Park, SA (
Sydney South West Private Hospital, Liverpool, NSW (
Austin Health, Heidelberg, VIC (

Status: Closed


Aucentra Therapeutics Announces The Completion of ATTACK-1 Study | 05.03.2024

Aucentra Therapeutics is thrilled to announce that the ATTACK-1 clinical study has successfully concluded! We are delighted to share that the results are positive, meeting all the study’s objectives. In summary, auceliciclib is safe and highly tolerable when administered as monotherapy or in combination with TMZ. Upon dosing, auceliciclib exhibits rapid absorption, leading to dose-proportional increases in plasma concentration.

The findings from this study provide valuable insights into the safety and efficacy of auceliciclib in treating advanced cancers. This information will play a crucial role in informing the next phase of clinical trials.

We are incredibly grateful to:
– the dedicated clinical research team who worked tirelessly to ensure the study’s success.
– the participants who volunteered their time and commitment to this important research.

We will be sharing more detailed information about the study results in the coming months through website updates, scientific publications and/or press releases.

Aucentra Therapeutics Announces Further Dose Escalation for Cohorts in ATTACK-1 Trial of Auceliciclib | 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 TMZ for recurrent/refractory GBM patients. As of 28 September 2022, dosing of auceliciclib has been completed for cohorts 1 – 5 of the monotherapy arm, and cohorts 1b – 2b of the combination therapy arm with TMZ. To date, auceliciclib have been well tolerated with no dose limiting toxicities observed in patients, 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 therapy 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:




Aucentra Therapeutics Announces Approval for Phase 1a/b Clinical Trial of Auceliciclib + TMZ in GBM Patients | 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 (TMZ) for recurrent/refractory glioblastoma multiforme (GBM) patients. To read more, click here.