German biotech company Mologen has entered a clinical trial collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) to assess the safety and efficacy of immunomodulator lefitolimod (MGN1703) in combination with immunotherapy Yervoy (ipilimumab) in advanced solid malignancies.
The Phase I trial has been designed to evaluate MGN1703 in combination with Bristol-Myers Squibb's checkpoint inhibitor ipilimumab in an expansion phase.
The study is called 'A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies'.
It is aimed at finding the highest dose of MGN1703 that can be tolerated in combination with ipilimumab by patients with advanced tumours.
MGN1703 and ipilimumab are two immunotherapies that help the body's immune system fight against cancer.
Yervoy is a recombinant, human monoclonal antibody and immune checkpoint inhibitor. It is approved to treat patients with unresectable or metastatic melanoma.
Mologen chief medical officer Dr. Alfredo Zurlo said: "Our study programme with lefitolimod as monotherapy in colorectal and lung cancer is on track.
"We are now moving to explore for the first time the combination of MGN1703 with a checkpoint inhibitor.
"Yervoy monotherapy can dramatically improve the outcome of a minority of melanoma patients; we hope to show that the combination with MGN1703 can expand both the frequency and potency of these responses."
Around 50-60 patients will be enrolled for the trial at MD Anderson's centre in Houston Texas, US.
Image: Small cell carinoma of the lung is also small cell lung cancer. Photo: courtesy of Nephron.