A Phase I First-In-Human Multicenter Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Brief description of study

The purpose of the study is to determine the safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine. This vaccine is based on a heterologous prime/boost regimen composed of the GAd20-209-FSP used for priming and MVA-209-FSP used for boosting in patients with unresectable or metastatic Mismatch Repair Deficient (dMMR) or Microsatellite Instability High (MSI-H) colorectal cancer (CRC), gastric and gastro-esophageal junction (G-E junction) tumors in sporadic or hereditary forms of the diseases. The vaccine has not been approved by FDA, but the FDA has given its permission to test this vaccine in the current trial.


Clinical Study Identifier: s20-01693
ClinicalTrials.gov Identifier: NCT04041310
Principal Investigator: Paul E. Oberstein.
Other Investigators: Daniel J Becker, Kristen Spencer, Keriann M Scavone, Nina Beri, Jennifer Chuy, Rafael Winograd, Shun Yu.


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