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Clinical Trial 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.


Clinical Trial Description

Methionine starvation can powerfully modulate DNA methylation, cell cycle transition, polyamines and antioxidant synthesis of tumor cells, in contrast to normal ones. L-Methioninase is a pyridoxal phosphate dependent enzyme that catalyzes the γ-elimination reaction of L-methionine to methanethiol, α-ketobutyrate and ammonia . Absolute-dependency on exogenous supply of L-methionine, not homocysteine, for growth and proliferation of tumors is the pivotal biochemical criterion for various human cancers. SGN1 is a genetically modified strain of Salmonella enterica, serotype typhimurium (VNP20009-M) that expresses L-Methioninase. The attenuated live bacterium has been investigated in China for utility in treating advanced solid tumors. 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. The study will be conducted in 3 parts.The study will employ a standard 3 + 3 escalating dose design to explore dose limiting toxicities (DLTs) in up to 5 sequential cohorts with 3- 6 patients to determine the maximally tolerated dose (MTD). Subjects who had no dose-limiting toxicities observed in Part 1 proceeded to Part 2. In part 2, SGN1 will be administered weekly until disease progression, unacceptable toxicity, withdrawal, death, or loss to follow-up.After OBD and responsive tumor type been determined, up to 10 participants/tumor type will be dosed in the expansion stage. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05038150
Study type Interventional
Source Guangzhou Sinogen Pharmaceutical Co., Ltd
Contact Alissa McGuire
Phone +1 919-259-4028
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date October 31, 2021
Completion date January 31, 2024

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