Date: 2015-05-05
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Merrimack Pharmaceuticals (USA - MA)
Product: MM-141 (istiratumab)
Action
mechanism: monoclonal antibody/bispecific antibody. MM-141 (istiratumab) is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). IGF-1R and ErbB3 complexes both activate a major signaling pathway that allows tumor cells to grow and develop resistance to chemotherapy. MM-141 has been tested in a Phase 1 dose-escalation clinical trial.
Disease: metastatic pancreatic cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The purpose of this study is to determine whether the combination of MM-141 (istiratumab) plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.(NCT02399137)
Latest
news: * On May 5, 2015, Merrimack Pharmaceuticals announced the initiation of a randomized, double-blinded, placebo-controlled Phase 2 clinical trial of MM-141 (istiratumab, a bispecific antibody targeting IGF-1R and ErbB3, in combination with nab-paclitaxel and gemcitabine, versus nab-paclitaxel and gemcitabine alone in patients with newly-diagnosed metastatic pancreatic cancer who have high serum levels of free IGF-1. As part of this trial, 146 front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1 will be randomized (1:1) to receive either MM-141 plus nab-paclitaxel/gemcitabine or nab-paclitaxel/gemcitabine alone. Eligible patients for the trial must have received no prior radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. The primary endpoint of the trial is progression free survival (PFS). Secondary endpoints include overall survival, objective response rate, safety and tolerability. Merrimack plans to conduct the trial at sites in the United States, Canada and Europe. Initial trial sites located at St. Jude Heritage in Fullerton, California and Northwestern University in Chicago, Illinois are now open to screen patients in the United States. The FDA has granted orphan drug designation for MM-141 for the treatment of pancreatic cancer.
