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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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days prior to first dosing, and at 2, 4, 6, and 24 hours post end of first infusion. for reporting.

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 more
Secondary study objectives
Assessment of tumor colonization
Immunogenicity (anti-drug antibodies)
Incidence of dose limiting toxicity (DLTs)
+6 more
Other 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.

Find a Location

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

SGN1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05103345 — Phase 1 & 2
Solid Tumors Research Study Groups: Cohort
Solid Tumors Clinical Trial 2023: SGN1 Highlights & Side Effects. Trial Name: NCT05103345 — Phase 1 & 2
SGN1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103345 — Phase 1 & 2
~45 spots leftby Dec 2027