Actively Recruiting
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
Led by Guangzhou Sinogen Pharmaceutical Co., Ltd · Updated on 2026-05-05
70
Participants Needed
4
Research Sites
271 weeks
Total Duration
On this page
Sponsors
G
Guangzhou Sinogen Pharmaceutical Co., Ltd
Lead Sponsor
P
Pharmaron
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years at the time of informed consent
- Patients with advanced or metastatic solid tumors refractory to standard therapy or intolerant to standard treatment
- Specific tumor types including HNSCC, sarcoma, HCC, cervical cancer, melanoma, or others with potential efficacy signal in Part 1
- Presence of at least one measurable lesion suitable for local intratumoral injection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Recovery from prior medication toxicities to Grade 1 or less (with specified exceptions)
- Laboratory tests within specified limits including neutrophils, platelets, hemoglobin, liver function, kidney function, and coagulation
- Female participants must be postmenopausal, surgically sterile, or non-pregnant and non-lactating with effective contraception if of childbearing potential
- Male participants must agree to use effective contraception
- Ability to comply with follow-up requirements
- Voluntary signed informed consent
You will not qualify if you...
- Prior treatment with oncolytic bacteria, viral, or anti-tumor bacterial therapy
- Tumors larger than 8 cm or multiple lesions not suitable for intratumoral injection
- Allergies or intolerance to salmonella-sensitive antibiotics or current infections requiring antibiotics
- Tumors present in hollow organs such as stomach, esophagus, or intestines
- Allergy to investigational drug or related medications
- Recent major surgery within 28 days prior to study drug administration
- Recent use of immunosuppressive drugs or live virus vaccines within specified timeframes
- Recent anti-tumor therapies within 28 days prior to study drug administration
- Active or symptomatic central nervous system metastases unless stabilized for 4 weeks
- Conditions promoting anaerobic bacterial growth in non-target lesions
- Symptomatic advanced disease with risk of life-threatening complications
- Active autoimmune diseases or history with expected recurrence (with some exceptions)
- Other active malignancies within 2 years except certain treated non-invasive cancers
- HIV infection, untreated active hepatitis B or C, or co-infection
- Uncontrolled or significant cardiac diseases
- Active or uncontrolled infections or fever above 38.5°C
- Documented salmonella infection within 6 months
- History of allogeneic organ or hematopoietic stem cell transplant
- Participation in other clinical trials within 4 weeks or 5 half-lives of other drugs
- History of psychotropic or recreational drug abuse
- Serious concurrent illnesses or conditions affecting safety or study compliance
- Presence of implants requiring long-term anticoagulant therapy
- Risk or evidence of bowel obstruction within 6 months prior to screening or judged unsafe by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Guangdong Clifford Hospital
Guangzhou, Guangdong, China, 511495
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
3
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Actively Recruiting
4
China Medical University Hospital
Taichung, Taiwan
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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