Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This clinical trial evaluated the safety and tolerability of CRS-100, an investigational
agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is
attenuated by genetic modification to limit cell to cell spread and invasion of liver cells.
These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of
the investigational agent to stimulate immunity in test animals and generate anti-tumor
activity in mice. The primary objective of this study was to determine the maximum tolerated
dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in
consenting volunteers. Immunological response to CRS-100 and tumor status of study
participants were also measured. Participation in this first clinical trial with CRS-100 was
restricted to adults with carcinoma refractory to standard treatment (or for whom no standard
treatment is available) and who additionally had liver metastases.