MabVax Therapeutics Holdings, Inc. Announces Completion of Enrollment and Dosing in Initial Cohort of MVT-1075 Radioimmunotherapy Phase 1 Trial for the Treatment of Pancreatic, Colon and Lung Cancers
December 13, 2017 at 07:30 am EST
MabVax Therapeutics Holdings, Inc. announced the completion of enrollment and dosing of all patients in the initial cohort of the Phase 1 clinical trial evaluating the Company's new human antibody-based radioimmunotherapy product MVT-1075 for the treatment of pancreatic, colon and lung cancer. This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 in approximately 22 patients with CA19-9 positive malignancies in the U.S. The primary objective is to determine the maximum tolerated dose and safety profile in patients with recurring disease who have failed prior therapies. Secondary endpoints are to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The investigative sites include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City.