Date: 2016-05-19
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Merrimack Pharmaceuticals (USA - MA) Baxalta (USA - IL)
Product: MM-151 in combination with Onivyde® (irinotecan liposome injection) plus fluorouracil and leucovorin
Action
mechanism: monoclonal antibody. MM-151 is Merrimack's wholly owned oligoclonal therapeutic mixture consisting of three fully-human monoclonal antibodies designed to bind and inhibit signaling of the epidermal growth factor receptor (EGFR). Onivyde® (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death.
Disease: RAS wild-type metastatic colorectal cancer (mCRC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On May 19, 2016, Merrimack Pharmaceuticals and Baxalta jointly announced the initiation of a Phase 1 clinical study of Merrimack's oligoclonal EGFR (epidermal growth factor receptor) inhibitor, MM-151, in combination with Onivyde® (irinotecan liposome injection) plus fluorouracil (5-FU) and leucovorin in patients with RAS wild-type metastatic colorectal cancer. Data from a prior Phase 1 study of MM-151 supports further clinical evaluation of the investigational therapy in patients with metastatic colorectal cancer. The initiation of this study advances the development path for Onivyde®.
This Phase 1 study will assess the safety and tolerability of the combination of MM-151, a novel antibody mixture of three human antibodies designed to target EGFR which promotes tumor growth, and Onivyde® , also known as MM-398 or "nal-IRI," plus 5-FU and leucovorin as first or second-line treatment in patients with RAS wild-type metastatic colorectal cancer. The trial will determine the side effect profile of MM-151 in combination with ONIVYDE plus 5-FU and leucovorin and recommended dose for subsequent trials with this combination. Eligible patients for the study must have metastatic disease, have had no prior exposure to irinotecan or an EGFR inhibitor, and have received no more than one prior line of treatment for metastatic disease. Merrimack plans to conduct the study at multiple sites in the United States . Merrimack will be solely responsible for the funding and execution of the Phase 1 study.
