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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

Study Summary

This trial is testing a new therapy to starve tumors of essential amino acids to help treat advanced solid tumors.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control rate (DCR)
Incidence of SAEs
Incidence of adverse events (AEs)
+2 more
Secondary outcome measures
Assessment of tumor colonization
Incidence of dose limiting toxicity (DLTs)
Proinflammatory cytokines
+5 more
Other outcome measures
Tumor biomarkers upon tumor types

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 disease progression. The standard 3+3 dose escalation algorithm will be applied to explore dose limiting toxicity (DLTs) in up to 5 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 several expansion cohorts will be opened to determine the safety and efficacy of SGN1 in specific tumor types with potential efficacy signal observed in the previous dose escalation study.

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
304 Previous Clinical Trials
101,082 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still active for this research program?

"Unfortunately, clinicaltrials.gov reveals that this trial has halted the recruitment of candidates since its initial posting on April 19th 2023 and most recent update from June 7th 2023. However, there are other medical trials conducting enrollment at present with a total 2667 patients needed for participation."

Answered by AI

Is this experiment open to individuals who exceed the age of 35?

"This research project has established a minimum age requirement of 18 years and an upper limit of 75 years for potential participants."

Answered by AI

What safeguards are in place to ensure patient safety during this treatment?

"Due to the limited evidence of safety and efficacy thus far, our team has assessed this treatment's security as a 1 on a scale from 1-3."

Answered by AI

What key milestones is this clinical trial seeking to achieve?

"The primary outcome of this trial, tracked from the first dose to 28 days after administration, is Remission Duration (RD). Secondary objectives include monitoring for Dose Limiting Toxicities and SGN1 levels in saliva and blood. Defined as Grade 5 events related to the investigational drug or Grade 3/4 non-hematologic toxicities lasting more than 7 days with optimal care or laboratory values requiring medical intervention; febrile neutropenia; thrombocytopenia combined with a Grade 3+ lymphatic disorder; AST/ALT associated with SGN1 level. Samples collected at each visit will be"

Answered by AI

What is the geographical scope of this clinical trial?

"There are 7 sites that are currently in operation for this trial, including Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare in New Taipei, Linkou Chang Gung Memorial Hospital in Taoyuan City, and China Medical University Hospital in Taichung."

Answered by AI

To what demographic is this trial open?

"The eligible patient population for this medical trial is between 18 and 75 years old, with solid tumors. In total, 50 volunteers are needed to complete the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
2023. "Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103345.
~47 spots leftby Dec 2027
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