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
winshipcancer.emory.edu

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