ACCENT Trial Recruitment Update
Released
Released
Announcement PDF
2nd Aug 2023
ASX RELEASE
ACCENT Trial Recruitment Update
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to provide an update on progress in the ongoing Phase 1b/2a ACCENT clinical trial in first-line
patients with advanced pancreatic cancer.
The current Phase 1b stage of the ACCENT trial is designed to test ascending doses of AMP945 in
patients, given in combination with gemcitabine and nab-paclitaxel. The dose-escalation stage will
cease, and a recommended dose for the Phase 2a stage of the trial identified, when either two or more
dose-limiting toxicities (DLTs) are observed and/or when the pharmacokinetic and pharmacodynamic
profiles are predicted to be optimised.
We are currently dosing the third cohort of patients in the dose-escalation phase of the trial. At this
time 12 patients have been dosed across the 3 cohorts and have completed their first full cycle of
treatment (28 days). Notably all patients, in consultation with their physicians, elected to stay on the
study drug after completion of the first cycle of treatment. A DLT signal was reported in one patient in
the current cohort, and consistent with the trial protocol, we expanded this third cohort with an
additional three patients. We are now pleased to report the final patient in this cohort has been
recruited and began dosing yesterday. Importantly, all other patients in this cohort have completed
their first full 28-day cycle and continue to remain on drug at this dose. In line with the study protocol,
we will continue to collect the data for this expanded cohort to determine whether further doseescalation is warranted. The combined data will be reviewed by the Safety Committee once all patients
in this cohort have been dosed for a complete 28-day cycle.
Amplia’s CEO and Managing Director Dr Chris Burns commented: “While the cohort expansion has
resulted in a delay for the complete data from this cohort to be reviewed by the safety committee, we
continue to be encouraged by the data reported from all trial sites. We are grateful for the patients
who are participating in the trial, and I look forward to reporting the outcomes from the Safety
Committee meeting next month.”
About the ACCENT Trial
The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the
Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and
Gemcitabine in Pancreatic Cancer Patients’.
The trial is a single-arm open label study conducted in two stages. The first, Phase 1b stage of the
trial, will determine an optimal dose of AMP945 by assessing the safety, tolerability,
pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in
combination with gemcitabine and nab-paclitaxel (Abraxane®) in first-line patients with advanced
pancreatic cancer.
The second, Phase 2a, stage of the trial is designed to perform an assessment of the optimal dose of
AMP945, in combination with gemcitabine and nab-paclitaxel, with the primary endpoint being
Objective Response Rate (ORR). Further endpoints will assess efficacy by other means as well as
safety and tolerability.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
More information about the ACCENT trial, including a list of participating sites, can be found via our
website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further
updates on the trial as recruitment proceeds.
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
About Amplia Therapeutics Limited
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the
field of cancer immunology and Amplia has a particular development focus in fibrotic cancers such as
pancreatic cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic
pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on Twitter
(@ampliatx) and LinkedIn.
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