How MEDI0562 works
An antibody is a protein the immune system produces to combat harmful foreign substances called antigens. MEDI0562 promotes an immune response against antigens found on the surface of cancer cells, destroying the cancer cells.
The binding prompts OX40 to help the T-cells survive and multiply. Activating OX40 also prevents regulatory T-cells from suppressing the immune system. Regulatory T-cells suppress the system to prevent it from attacking healthy cells, but the suppression can help cancer cells survive and grow.
MEDI0562 in clinical trials
Advanced solid tumors
An open-label, multicenter Phase 1 clinical trial (NCT02318394) is evaluating MEDI0562’s safety and ability to trigger an immune response in adults with selected advanced solid tumors. The study is also assessing patients’ ability to tolerate the therapy.
The trial has two phases — a dose escalation phase and a dose expansion phase. The first phase is evaluating six levels of MEDI0562 injected into the bloodstream, with different trial participants receiving different doses. Researchers are assessing patients’ tumors every eight weeks to see how they respond to the various doses.
In the second part of the trial, patients’ doses are increased over time. Preliminary data from the dose escalation phase showed that the 27 patients tolerated the therapy well and that it displaying signs of effectiveness against advanced solid tumors.
The trial is continuing in the United States and Korea but no longer recruiting participants.
Another open-label, multicenter Phase 1 trial (NCT02705482) is recruiting adults with advanced solid tumors in the United States, Australia, France, and the Netherlands.
It will evaluate the safety and effectiveness of a combination of MEDI0562 and one of two other monoclonal antibodies — either Imfinzi (durvalumab) or tremelimumab. Imfinzi targets the PD-L1 protein and tremelimumab the CTLA-4 protein on the surface of cancer cells.
This study also has two phases — a dose escalation and a dose expansion phase. Each phase has two treatment arms. One group will receive a combination of MEDI0562 and Imfinzi, and the other a combination of MEDI0562 and tremelimumab. The study is expected to be completed by 2023.
A Phase 2 trial (NCT03267589) aims to evaluate the safety and effectiveness of a combination of MEDI0562 and either Imfinzi or tremelimumab as a treatment for ovarian cancer that has returned. Recruitment has yet to start for this trial, which will take place in Denmark, Finland, and Norway. The study is expected to be completed by 2022.
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