MabVax Therapeutics has started dosing patients in the initial round of a Phase l clinical trial evaluating MVT-1075 for the treatment of pancreatic, colon and lung cancers.
The company has also completed enrolling patients for the trial, which is an open-label, multi-centre study that includes around 22 patients with CA19-9 positive malignancies in the US.
The primary objective of the trial is to determine the maximum tolerated dose and safety profile in patients with the recurring disease who have failed prior therapies.
Secondary objects include the evaluation of tumour response rate and duration of response by response evaluation criteria in solid tumours (RECIST) 1.1 standard, as well as the determination of dosimetry and pharmacokinetics.
The dose-escalation study employs a traditional 3+3 design and includes Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City as investigative sites.
Interim results from the study are expected to be released by the first quarter of next year.
MabVax’s MVT-1075 is a new human antibody-based radioimmunotherapy (RIT) product that combines existing efficacy of radiation therapy with tumour-specific targeting.
The drug has the potential to deliver a more potent HuMab-5B1-based product. It uses small doses of MVT-5873 antibody developed by MabVax with a radioisotope to target and kill pancreatic cancer cells.
In April, MabVax presented preclinical results of MVT-1075 at the American Association of Clinical Research (AACR) annual meeting, demonstrating marked suppression, and in some instances, regression of tumour growth in xenograft animal models of pancreatic cancer.