Actively Recruiting
Study of SGN1 in Patients With Advanced Solid Tumor
Led by Guangzhou Sinogen Pharmaceutical Co., Ltd · Updated on 2026-05-05
70
Participants Needed
8
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objectives:To assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1 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 therapy and for which no other conventional therapy exists.
CONDITIONS
Official Title
Study of SGN1 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive, any gender
- Patients with advanced or metastatic cancer refractory to standard therapies or intolerant to them
- Specific tumor types included in dose expansion phase after evaluation
- Completed anti-tumor treatments at least 4 weeks prior to first dose
- At least one measurable tumor lesion
- Recovered or stable from prior medication toxicities (mostly Grade 1 or less)
- ECOG performance status 0 to 1 with life expectancy of at least 3 months
- Laboratory values within specified ranges and no blood cell growth factor within 14 days prior
- Female participants must be postmenopausal, surgically sterile, or non-pregnant and non-lactating
- Female participants of childbearing potential must use contraception until 6 months post-treatment
- Male participants of reproductive potential must use contraception until 6 months post-treatment
- Patients with controlled chronic HBV or treated HCV infections as specified
- Ability to comply with follow-up visits
- Voluntarily sign informed consent
You will not qualify if you...
- Use of systemic steroids equivalent to prednisone >10 mg/day within 14 days prior
- Allergy or intolerance to salmonella-sensitive antibiotics or current antibiotic use
- Tumors in hollow organs such as stomach, esophagus, intestine, or urinary tract
- Symptomatic central nervous system metastases or brain abscess
- Diverticulitis or conditions promoting anaerobic bacteria growth outside target tumors
- Uncontrolled or significant cardiac conditions including heart failure NYHA grade 2 or above, unstable angina, recent myocardial infarction, significant arrhythmias, uncontrolled hypertension, or valvular heart disease
- Anti-tumor therapy ended fewer than 4 weeks prior (6 weeks for nitrosourea or mitomycin chemotherapy)
- Active or uncontrolled infections or fever >38.5°C not caused by tumor
- Positive HIV-1 or HIV-2 tests
- Positive for anti-TP (syphilis antibody)
- Participation in other clinical trials within 4 weeks or 5 half-lives of other study drugs
- Vaccination with live or attenuated vaccines within 4 weeks before or during study
- Serious diseases or conditions affecting safety or data integrity
- Documented salmonella infection within 6 months
- Evidence or risk of bowel obstruction within 6 months
- Presence of pacemakers, prosthetic cardiac valves, or metal orthopedic prostheses (except vascular implants in Part 3)
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Suspended
2
Health Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Suspended
3
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Withdrawn
4
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Suspended
5
Guangdong Clifford Hospital
Guangzhou, Guangdong, China, 511495
Actively Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
7
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
8
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yifan Xu
CONTACT
W
Weiyun Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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