Merrimack Pharmaceuticals, along with Baxalta, has begun a Phase l clinical trial of MM-151 in combination with onivyde (irinotecan liposome injection), fluorouracil (5-FU) and leucovorin to treat RAS wild-type, metastatic, colorectal cancer patients.
Merrimack’s MM-151 is an oligoclonal, epidermal growth factor receptor (EGFR) inhibitor that contains three fully-human monoclonal antibodies designed to bind and inhibit signalling of the EGFR.
The drug has previously been tested in a Phase l dose-escalation clinical trial in patients with advanced solid tumours.
Onivyde (irinotecan liposome injection), also known as MM-398 or ‘nal-IRI’, is a new encapsulation of irinotecan in a liposomal formulation.
The Phase l trial will evaluate the safety and tolerability of the combination of MM-151 and onivyde, as well as 5-FU and leucovorin as first or second-line treatment in patients with RAS wild-type, metastatic, colorectal cancer.
The trial expects to determine the side effect profile of MM-151 in combination with onivyde, 5-FU and leucovorin and the recommended dose for subsequent trials with this combination.
Patients to be enrolled for the trial must have metastatic disease and have had no prior exposure to irinotecan or an EGFR inhibitor, as well as have received no more than one prior line of treatment for metastatic disease.
Merrimack plans to perform the study at multiple sites in the US.
Vanderbilt-Ingram Cancer Center, US, medicine associate professor and principal investigator of the trial Dr Emily Chan said: "Metastatic colorectal cancer remains a deadly disease, with only 11% of patients surviving five years or longer.
"As our understanding of the dynamics of cancer cells increases, we are able to develop and explore novel targeted combination therapies to combat this deadly disease.
"This study is a significant step forward towards addressing this unmet medical need, and providing a potential new treatment option to patients facing this deadly disease."
Merrimack and Baxalta have entered into an exclusive licensing agreement to develop and commercialise onivyde outside the US.