US-based biopharmaceutical firm Merrimack Pharmaceuticals has started patient enrolment in a Phase I clinical trial of MM-310 for the treatment of solid tumours.
MM-310 is an antibody-directed nanotherapeutic (ADN) with a chemotherapy prodrug docetaxel encapsulated in a liposome.
The product is being developed to target the protein ephrin receptor A2 (EphA2) that is reported to be found in several tumour types such as prostate, ovarian, bladder, gastric, pancreatic and lung cancers.
The open-label Phase I trial is designed to evaluate the safety, pharmacology and preliminary activity of MM-310 in three parts.
Merrimack medical director and MM-310 project leader Vasileios Askoxylakis said: "The initiation of this study is an important step in evaluating MM-310's safety and preliminary activity in patients diagnosed with solid tumours.
"MM-310 was designed to maximise targeted delivery and local activation of a newly engineered and proprietary prodrug of docetaxel, a broadly used potent chemotherapy that is often associated with significant drug-related toxicities with a goal of minimising exposure to healthy tissue.
"In several preclinical models, MM-310 not only demonstrated superior anti-tumour activity when compared to free docetaxel, but also fewer hematologic toxicities."
The first part of the trial will determine the maximum tolerated dose (MTD) of MM-310 as a monotherapy, while the concurrent parts include an expansion cohort as a single agent and a dose-finding phase in combination with other therapies.
It is expected that five sites will participate in the trial and the results from the first part will be reported next year.