Antengene has dosed the first subject in the Phase I STAMINA-001 clinical trial of ATG-037 in locally advanced or metastatic solid tumour patients in Australia.
An orally available, small molecule inhibitor of CD73, ATG-037 is claimed to have the potential to reverse immunosuppression mediated by adenosine.
The company holds exclusive international rights for the development, marketing and production of ATG-037.
The open-label, multicentre, dose-finding trial will assess ATG-037 as a monotherapy or in combination with pembrolizumab in subjects with locally advanced and metastatic solid tumours.
Initially, participants will start with two monotherapy cycles and subsequently receive pembrolizumab, an immune checkpoint inhibitor.
Analysing the safety, tolerability, initial efficacy and detecting the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and/or the optimal biological dose of ATG-037 monotherapy is the trial’s primary goal.
Characterising ATG-037’s pharmacology will be included as the trial’s secondary objective.
Furthermore, the company will carry out a rigorous monitoring of safety throughout the trial.
Antengene chief medical officer Dr Kevin Lynch said: “Developing agents that can act in the tumour microenvironment to reverse immunosuppression is one of the key focus areas for Antengene.
“We have been very pleased with the drug’s performance in preclinical studies and are hopeful that in this Phase I study ATG-037 can demonstrate the tolerability and signals of activity that will allow us to move forward into a broader development programme.”
The latest development comes after the company dosed the first subject in Phase I/II SWATCH study of Xpovio (selinexor) plus lenalidomide and rituximab for treating relapsed/refractory diffuse large B-cell lymphoma and relapsed/refractory indolent non-Hodgkin lymphoma.