Antengene has dosed the first subject in the Phase I PROBE-CN clinical trial of ATG-101 as a single agent in advanced/metastatic solid tumour or B-cell non-Hodgkin lymphoma (B-NHL) patients in China.
The multicentre, open-label trial will analyse the safety and tolerability of intravenous doses of ATG-101 monotherapy in these patients.
To be carried out at four centres in China, the trial will have dose-escalation and dose-expansion parts.
Shanghai East Hospital of Tongji University is the lead site for the trial.
A new PD-L1/4-1BB bispecific antibody, ATG-101 can hinder the immunosuppressive PD-1/PD-L1 binding and temporarily prompt 4-1BB stimulation.
This in turn activates anti-tumour immune effectors while providing improved anti-tumour activity with an enhanced safety profile.
It is said to be the first molecule developed in-house by the company with worldwide rights.
ATG-101 showed substantial anti-tumour activity in animal models of resistant tumours and those that advanced following anti-PD-1/L1 therapy, in preclinical studies.
Additionally, in Good Laboratory Practice (GLP) toxicology studies, the antibody demonstrated a safety profile.
ATG-101 has so far obtained regulatory clearances in the US, Australia and China to enter the Phase I trial to treat advanced/metastatic solid tumours and NHL.
The company has already initiated the trial in Australia and China and is set to commence soon in the US.
Antengene chief medical officer Dr Kevin Lynch said: “Compounds that combine the well-established efficacy of inhibition of the PD-1/PD-L1 axis with activation of 4-1BB represent a fascinating opportunity in oncology.
“In our view, ATG-101’s ability to activate exhausted T-cells and render ‘cold tumours’ hot has the potential to open the door to wide applicability in resistant/relapsed diseases.
“These qualities, together with a robust preclinical data package, position ATG-101 to be a potentially best-in-class molecule.”
In May this year, the company dosed the first patient in the Phase I STAMINA-001 trial of ATG-037 for locally advanced or metastatic solid tumours in Australia.