A Beta-only IL-2 ImmunoTherapY (ABILITY) Study
Providence Saint John's Health Center, Santa Monica, California, United States|Boca Raton Regional Hospital, Boca Raton, Florida, United States|Orlando Health Cancer Institute, Orlando, Florida, United States|Emory - Winship Cancer Institute, Atlanta, Georgia, United States|Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia|Scientia Clinical Research, Randwick, New South Wales, Australia|Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia|Princess Margaret Cancer Center, Toronto, Ontario, Canada
Drug: MDNA11 Monotherapy|Drug: MDNA11 in combination with checkpoint inhibitor
The study drug, MDNA11, is a selective IL-2 preferentially activating effector T cells (naïve CD8+ T-cells) and NK cells responsible for killing cancer cells, with minimal or no stimulation of the immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.
The study will be conducted at up to 16 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in two parts:
Sequential Dose Escalation
Dose Expansion in monotherapy as well as with an immune checkpoint inhibitor.
Approximately 100 patients will be enrolled.
Tumor assessment by CT/MRI will be performed every 12 weeks and will continue until documented disease progression. Treatment may continue for up to 1 year, or until treatment discontinuation criteria are met. Patients can withdraw from participation at any time.