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Virus Therapy

SGN1 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
Patients aged 18-75 years inclusive of end value, regardless of gender
Patients with Eastern Co-Operative Oncology Group (ECOG) performance status 0-1 and a life expectancy of at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion.
Awards & highlights

Study Summary

This trialtests a new therapy for cancer patients with tumors that don't respond to standard treatments. It uses a modified bacteria to starve the tumor of essential amino acids.

Who is the study for?
This trial is for adults aged 18-75 with advanced solid tumors that haven't responded to standard treatments or have no other treatment options. Participants must have at least one measurable tumor, be in relatively good health (ECOG status 0-1), and have a life expectancy of over three months. Women must not be pregnant or breastfeeding and use contraception if of childbearing potential; men also need to agree to use contraception.Check my eligibility
What is being tested?
SGN1, a genetically modified Salmonella bacterium designed to target and kill cancer cells by starving them of methionine, an amino acid essential for tumor growth. This study will first determine the safe dosage levels (safety/tolerability) followed by an expansion phase to assess preliminary effectiveness against various refractory solid tumors.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with bacterial infections such as fever, chills, fatigue along with site-specific inflammation due to bacteria accumulation in the tumors. As SGN1 is a new therapy, there may be unforeseen side effects related to its unique mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am mostly active and my doctor expects me to live at least 3 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days prior to the first dose, 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 the first dose, 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 and severity of AEs (adverse events).
Incidence of SAEs.
+2 more
Secondary outcome measures
Anti-Drug antibody (ADA) of SGN1.
Assessment of tumor colonization.
Bacterial shedding of SGN1 level in blood.
+7 more
Other outcome measures
Tumor biomarkers upon cancer types

Trial Design

1Treatment groups
Experimental Treatment
Group I: CohortExperimental Treatment1 Intervention
In part 1&2, cohorts of 3 patients will be enrolled. The first patient of each cohort in Part 1 will be admitted to an infusion unit and treated with an IV infusion of SGN1 over 2 hours. Patients in Part 1 will enter Part 2 for extension treatment after completing the 28-day DLT observation period. Up to 5 cohorts will be evaluated. Part 3 is an open-label, dose expansion phase.There will be at least 2 tumor types selected, expand between second to four dose level in each tumor type .

Find a Location

Who is running the clinical trial?

Novotech Clinical Research USA, LLCUNKNOWN
ClinChoice Enterprise Management (Shanghai) Limited Co., LtdUNKNOWN
ParexelIndustry Sponsor
302 Previous Clinical Trials
100,624 Total Patients Enrolled

Media Library

SGN1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05038150 — Phase 1 & 2
Solid Tumors Research Study Groups: Cohort
Solid Tumors Clinical Trial 2023: SGN1 Highlights & Side Effects. Trial Name: NCT05038150 — Phase 1 & 2
SGN1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038150 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals still being accepted to join this clinical experiment?

"Affirmative. According to the clinicaltrials.gov page, this medical trial is presently looking for participants and was first posted on September 30th 2022. The study requires 50 volunteers from 4 separate locations to complete their research."

Answered by AI

Is the age limit for recruitment in this research study above eighty years?

"This medical trial has established that eligible participants must be between 18 - 75 years old. Additionally, there are 303 studies for minors and 2316 trials for seniors."

Answered by AI

Has Cohort received regulatory approval from the FDA?

"The safety of Cohort has been rated 1 on a scale of 1 to 3 due to the limited data that exists in support of its efficacy and security, as it is currently undergoing Phase 1 trials."

Answered by AI

What is the upper limit for participant enrollment in this investigation?

"Indeed, current information on clinicaltrials.gov affirms that this medical study is actively recruiting participants. It was initially posted on September 30th 2022 and the most recent update occurred November 23rd of the same year. This experiment requires 50 individuals to be recruited from 4 separate sites for participation."

Answered by AI

How widely dispersed are the sites conducting this research within the state?

"Presently, this medical research is being conducted at four different clinics—namely in Orange, Gilbert and Detroit as well as another undisclosed site. To reduce the burden of travel for participants, interested individuals should choose to enroll with the facility closest to them."

Answered by AI

Is there an opportunity for my involvement in this experiment?

"This medical trial is recruiting fifty participants between the ages 18 and 75 with advanced solid tumors. To be eligible, patients must meet a variety of criteria including age range (including end value), failure of standard treatment or inability to receive it, having at least one measurable lesion according to RECIST 1.1 for solid tumors, recovering from any toxic reaction to prior medications (with certain exceptions) an Eastern Co-Operative Oncology Group performance status 0 ~ 1, life expectancy of three months or more and haematological parameters such as absolute count of neutrophils (ANC), platelet counts, hemoglobin levels etc."

Answered by AI

What is the ultimate goal of this research project?

"The primary endpoint of this trial, assessed from the administration of medication through 28 days following the final dose, is to ascertain the incidence of adverse events. Secondary endpoints include determining SGN1 presence in urine samples collected within two hours prior to infusion and 24 hours after its completion; measuring biodistribution and shedding levels in blood and excrement; evaluating bacterial shedding in oral mucosa, anogenital region samples, injected site exterior, occlusive dressings; as well as recording any incident of associated side effects."

Answered by AI
~47 spots leftby Jan 2028