The open-label, multi-centre, dose-escalation, and expansion clinical study has been designed for evaluating ATRN-119 as a monotherapy in advanced solid tumours patients.
Its initial part will assess the pharmacokinetics, tolerability, recommended Phase II dose, and analyse the patient biomarkers.
The trial’s Phase IIa expansion part will further assess ATRN-119’s efficacy and tolerability as a monotherapy.
The findings from the trial are expected during this year.
Karolinska Development CEO Viktor Drvota said: “The dosing of the first patient in the clinical Phase I/IIa trial of ATRN-119 marks an important milestone in Aprea Therapeutics’ efforts to develop a pipeline of drug candidates that inhibit DNA repair in tumours.
“The drug candidate differs from other ATR inhibitors and has shown a potent effect on a variety of cancer cell lines in preclinical studies, and we look forward to following the results from the study during the year.”
The new macrocyclic ATR inhibitor, ATRN-119, has been designed for affecting the proteins that are involved in the tumours’ ability to repair the damage in their DNA.
It is currently being assessed as a monotherapy, as well as in combination with standard therapy to treat malignant solid tumours.
In May last year, Aprea Therapeutics added ATRN-119 to its project portfolio through the purchase of US-based private biopharmaceutical company Atrin Pharmaceuticals.
In 2021, the company had announced that the US Food and Drug Administration (FDA) placed a clinical hold on the clinical trial of eprenetapopt (APR-246) to treat lymphoid malignancies.