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Virus Therapy
SGN1 Injection for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Guangzhou Sinogen Pharmaceutical Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days prior to first dosing, and at 2, 4, 6, and 24 hours post end of first infusion.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests SGN1, a modified bacterium injected into tumors, in patients with advanced solid tumors that don't respond to other treatments. SGN1 works by starving the tumor of a vital nutrient, methionine. The study aims to find the safest and most effective dose while checking for any side effects.
Who is the study for?
Adults aged 18-75 with advanced solid tumors that haven't responded to standard treatments or for whom no standard treatment exists. They must have a life expectancy of at least 12 weeks, an ECOG score of 0-1, and be able to follow up post-treatment. Women of childbearing age must use contraception.
What is being tested?
SGN1 is being tested as a potential cancer therapy for its ability to starve tumors by depleting essential amino acids. It's administered directly into the tumor and this study aims to find the safest dose with the best response in various advanced cancers.
What are the potential side effects?
Specific side effects are not listed but generally may include local reactions at injection sites, potential immune responses due to bacterial components, and typical symptoms associated with oncolytic therapies such as fever or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days prior to first dosing, and at 2, 4, 6, and 24 hours post end of first infusion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days prior to first dosing, and at 2, 4, 6, and 24 hours post end of first infusion.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease control rate (DCR)
Incidence of SAEs
Incidence of adverse events (AEs)
+2 moreSecondary study objectives
Assessment of tumor colonization
Immunogenicity (anti-drug antibodies)
Incidence of dose limiting toxicity (DLTs)
+6 moreOther study objectives
Expression changes of tumor immune microenvironment related indicators in tumor tissue
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CohortExperimental Treatment1 Intervention
SGN1 will be injected into the target lesion intratumorally. According to the dose levels, the administered dose will be 0.5×108 CFU, 1×108 CFU, 2×108 CFU, 4×108 CFU, 6×108 CFU (optional). The patient will be administered once every week for 3 consecutive weeks followed by 1-week rest in 28-day treatment cycles. The duration of administration is until isease complete response/inability to continue intratumoral administration or disease progression, or intolerable toxicity or death or voluntary withdrawal or end of study, whichever came first.
The standard 3+3 dose escalation algorithm will be applied to explore dose limiting toxicity (DLTs) in at least 4 sequential cohorts with 3- 6 patients and identify the maximally tolerated dose (MTD).
When the cohort is completed in Part 1, the Part 2 study could be started according to the SMC evaluation. Enrollment of 2-4 dose level expansions will be opened to determine the safety and efficacy of SGN1 in specific tumor types
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The mechanism of action for SGN1 involves using a tumor-targeting bacterium to deliver L-Methioninase, an enzyme that depletes the tumor of essential amino acids like methionine, crucial for tumor growth. This method targets the metabolic vulnerabilities of cancer cells.
Other common treatments for solid tumors include chemotherapy, which targets rapidly dividing cells; radiation therapy, which damages cancer cell DNA; and immunotherapy, which boosts the immune system's response against cancer cells. These treatments are vital for solid tumor patients as they provide multiple strategies to combat cancer, potentially improving outcomes and survival rates.
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Who is running the clinical trial?
PharmaronUNKNOWN
3 Previous Clinical Trials
113 Total Patients Enrolled
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,725 Total Patients Enrolled
Guangzhou Sinogen Pharmaceutical Co., LtdLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition is not well controlled with treatment.I agree to use effective birth control methods.I have active brain metastases that are not under control.I am allergic or cannot tolerate certain antibiotics and am currently being treated for an infection.I am between 18 and 75 years old.I had a salmonella infection in the last 6 months.I have received certain treatments or drugs before starting the trial drug.I have been treated with bacteria to fight cancer.I have not had any other cancer types in the last 2 years.I have HIV or active, untreated hepatitis.I am not allergic to the trial drug, its components, rescue medications, or monoclonal antibodies.My cancer can be measured and is located in organs like the stomach or intestines.I meet the specific requirements regarding menopause, sterility, pregnancy, and contraception.I have diverticulitis or a condition that increases anaerobic bacterial growth.I am fully active or can carry out light work.My main cancer lesion can be injected directly.My advanced cancer has not responded to standard treatments, or I cannot tolerate them.I do not have an ongoing infection or unexplained fever.I can attend all follow-up appointments after treatment.I have had signs of a blocked intestine in the last 6 months.My tumor is too large or I have too many tumors for direct injection treatment.I have recovered from side effects of previous treatments, except for minor issues like hair loss.I have a specific type of advanced cancer and standard treatments haven't worked or I can't tolerate them.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.