Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor

Active:	Yes
Cancer Type:	Cervical Cancer Head and Neck Cancer Liver Cancer / Hepatoblastoma Melanoma Sarcoma Skin Cancer (Non-Melanoma) Solid Tumor Unknown Primary	NCT ID:	NCT05103345
Trial Phases:	Phase I Phase II	Protocol IDs:	SGN-P01-002 (primary) NCI-2023-06281
Eligibility:	18 - 75 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Guangzhou Sinogen Pharmaceutical Co., Ltd
NCI Full Details:	http://clinicaltrials.gov/show/NCT05103345

Summary

Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of
SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy
and safety of SGN1 in specific tumor subtypes at OBD doses.

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: Patients presenting with histologically confirmed advanced and/or
metastatic solid tumors that are refractory to standard therapy and for which no other
conventional therapy exists.

Objectives

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 ?-elimination
reaction of L-methionine to methanethiol, a-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 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.

This study is a multi-center phase I/IIa clinical trial with 2 parts:

Part 1 is a phase I open-label, dose escalation study phase. The purpose of Part 1 is to
characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients
with advanced solid tumors. Part 2 is as a part of a phase Ib/IIa study, which is a specific
Tumor-type expansion study, the purpose of Part 2 is to preliminarily investigate the
efficacy and safety of SGN1 in specific tumor subtypes at Safety Monitoring Committee (SMC)
determined doses.

SGN1 will be administrated in 28-days cycles (once weekly for 3 weeks followed by 1-week
rest). Intratumoral injection of SGN1 can be performed directly using methods including but
not limited to color doppler ultrasound guidance, which is the preferred method. If the
Investigator(s) judge(s) it necessary, the tumor can also be injected under CT guidance by an
interventional radiologist or specialist with adequate qualifications and trainings.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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