An open Phase I/II dose escalation and expansion study of MDNA11, an IL-2 superagonist, administered alone or in combination with an immune checkpoint inhibitor in patients with advanced solid tumors (ABILITY-1 STUDY)

This study investigates a new form of a cytokine (a type of immunotherapy) called MDNA11. The study aims to evaluate the safety and tolerability of the investigational drug (MDNA11) and to determine the appropriate dose for further evaluation. Additionally, the study will assess the preliminary anti-cancer activity of this investigational drug, either alone or in combination with another immunotherapeutic agent (Pembrolizumab). Pembrolizumab is a medication that is approved for many types of tumors (under the name KEYTRUDA). Your doctor will explain whether you will receive MDNA11 alone or in combination with Pembrolizumab. Your doctor will also explain whether Pembrolizumab is approved for your specific type of tumor. Participation in the study typically lasts about 4 to 24 months (depending on the number of doses administered). The first 3 months require about 11 study visits; starting from the 4th month, visits will occur every two weeks. For a 24-month participation, the total number of visits will be about 56. Each visit may last up to 8 hours.

The aim of this study is to evaluate the safety and efficacy of a novel immunotherapy called MDNA11. An investigational immunotherapy means that it has not yet been approved by regulatory authorities (e.g., European Medicines Agency (EMA), United States Food and Drug Administration (US FDA), Therapeutic Goods Administration (TGA) in Australia, Swissmedic in Switzerland) for use outside of clinical trials. MDNA11 is a humanized recombinant therapeutic interleukin-2 (IL-2) molecule that is bound to albumin. IL-2 is a natural protein that helps stimulate your body's immune responses. In MDNA11, the IL-2 molecule has been modified to stimulate cancer-killing immune cells and reduce the activation of other immune cells that hinder your body's cancer-fighting ability. The theory behind this drug is that it can 'turn on' your own immune system to fight your cancer and may also help limit the side effects that occur with other approved IL-2 therapies.

You are being asked to participate in this clinical research study because you have been diagnosed with an advanced solid tumor that is not responding or no longer responding to standard therapy.