Phase I Study of SGN1 in Patients With Advanced Solid Tumor
Status:
Not yet recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
Summary
Objectives:To assess the safety and tolerability followed by a dose expansion study to
characterize safety, and preliminary efficacy of SGN1,a genetically modified strain of
Salmonella enterica, serotype typhimurium (VNP20009-M) that expresses L-Methioninase,in
participants with refractory solid tumors.
Study Rationale:The mechanism of action for SGN1 is based on the fact that most tumors are
methionine dependent. SGN1 is designed to be used as a tumor therapeutic bacterium that can
preferentially replicate and accumulate in tumors and starve them of essential amino acids by
delivering the oncolytic enzyme L-Methioninase.
Patient Population:The treatment populations shall be patients presenting with histologically
confirmed advanced and/or metastatic solid tumors that are refractory to standard curative
therapy and for which no other conventional therapy exists.