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SGN1 for Solid Tumors
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have chronic HBV or a history of HCV and meet specific health criteria.I am between 18 and 75 years old.I can attend all follow-up appointments after treatment.I agree to use effective birth control methods.I had a salmonella infection in the last 6 months.I have tested positive for a specific infection or disease.I do not have an active or uncontrolled infection or fever.I meet the specific requirements regarding menopause, sterility, pregnancy, and contraception.I have not taken steroids in the last 14 days.I am allergic or cannot tolerate certain antibiotics, or I am currently on antibiotics.I have not had specific treatments recently.My cancer did not respond to standard treatments or I couldn't tolerate them.I finished my cancer treatment at least 4 weeks ago.I am mostly active and my doctor expects me to live at least 3 more months.My advanced cancer has not responded to standard treatments, or I cannot undergo them.
- Group 1: Cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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