Antengene has received the go ahead from the Bellberry Human Research Ethics Committee (HREC) in Australia to commence the Phase I STAMINA trial of the company’s ATG-037 to treat locally advanced or metastatic solid tumour patients.
ATG-037 is an oral, small-molecule inhibitor of the cluster of differentiation 73 (CD73). CD73 produces adenosine, which causes immunosuppression in the microenvironment of the tumour.
The primary goal of this first-in-human trial is to analyse the safety, tolerability and initial efficacy of ATG-037 as a single agent or along with an immune checkpoint inhibitor (CPI) in individuals with locally advanced or metastatic solid tumours.
This will aid in determining a suitable dose of ATG-037 for Phase II trials.
Furthermore, the trial will analyse the pharmacology of the therapy as the secondary goal.
Antengene chief medical officer Kevin Lynch said: “Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors.”
“ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programmes.”
In preclinical studies, ATG-037 showed to defeat the ‘hook effect’ usually associated with anti-CD73 antibodies and demonstrated to have a wider therapeutic window in GLP toxicology studies.
The company dosed the first subject in the Phase I PROBE trial of ATG-101 in metastatic/advanced solid tumour and B-cell non-Hodgkin’s lymphoma (B-NHL) patients in Australia, in December last year.