Phase 1 trial evaluating MVT-5873 in combination with first-line chemotherapy in pancreatic cancer: promising early results
Interim results from the ongoing phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in patients newly diagnosed with pancreatic and other CA19-9 positive malignancies were announced.
At the dose tested, all six patients in the cohort had meaningful reductions in tumor volume by RECIST.
MVT-5873, a fully human antibody, was given in combination with nab-Paclitaxel and Gemcitabine to patients newly diagnosed with CA19-9 positive pancreatic cancer.
MVT-5873 at a dose of 0.125 mg/kg when added to first-line chemotherapy was generally well tolerated by all subjects.
All six patients had measurable tumor reductions, with four patients meeting the criteria for partial response ( PR ) and two patients meeting the criteria for stable disease ( SD ).
These results confirm results reported from a group of patients treated earlier.
Patient CA19-9 levels, which are a prognostic indicator of the disease state, were markedly reduced in all subjects with this combination therapy.
This phase 1 clinical trial is an open-label, multi-center non-randomized study evaluating the safety and recommended phase 2 dose of MVT-5873 in combination with a standard of care chemotherapy in subjects with pancreatic and other CA19-9 positive malignancies.
Secondary objectives include evaluating tumor response rate by RECIST 1.1, duration of response, and to determine pharmacokinetics.
This study utilizes a conventional 3+3 design to identify the recommended phase 2 dose. ( Xagena )
Source: MabVax Therapeutics, 2018