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NG-641 for Advanced Cancer (STAR Trial)
STAR Trial Summary
This trial is testing a new drug, NG-641, to see if it is safe and tolerated by patients with metastatic or advanced epithelial tumours.
STAR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STAR Trial Design
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Who is running the clinical trial?
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- Your doctors believe you have at least 6 months or more to live.You have either had or are planning to have a bone marrow or organ transplant using donor or your own cells.The location or size of your tumor is considered risky if there is a chance of tumor flare-up or tissue death.You are allowed to continue taking bisphosphonate therapy or RANK-ligand inhibitors for bone disease that has spread.You have good lung function.You have previously experienced a severe kidney injury or have significant kidney problems.You have had a serious infection or inflammation in your bowel within the last 3 months before starting the study treatment.You have experienced a serious heart, blood vessel, or blood clotting problem within the past 6 months.You have taken chemotherapy, targeted small molecule drugs, or other experimental medications within 14 days or five half-lives (whichever is shorter) before starting the study treatment.You are allergic to both cidofovir and valacyclovir.You have had another type of cancer in the past 3 years, unless there are special circumstances mentioned in the study protocol.You have cancer that has spread to your brain or the protective covering of your brain, and it is causing symptoms or needs treatment.You have advanced cancer that has either come back after treatment or is not responding to standard treatments.You have received any vaccine, including COVID-19 vaccines, within 7 days before starting the NG-641 treatment.You are currently experiencing severe depression that is affecting your daily life.You have used certain treatments in the past.You are allergic to NG-641 transgene, immune checkpoint inhibitors, or other monoclonal antibodies.You have a history of serious lung disease or inflammation that is not caused by an infection.You have received treatment with enadenotucirev or any medication that targets fibroblast activation protein (FAP).You have received certain types of cancer treatments in the last 28 days, except for a type of therapy called PD-1/PD-L1 therapy.
- Group 1: Intravenous
- 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
Is this study open to new participants?
"Information hosted on clinicaltrials.gov affirms that this research initiative, first posted on January 23rd 2020, is actively searching for participants. The details of the trial have been revised most recently in February of 2022."
What is the geographic scope of this research trial?
"This research is enrolling patients from Washington University Medical School, MD Anderson in Houston and UCLA's Santa Barbara campus. Additionally, there are 5 more clinical trial sites listed on the study page."
What is the cap for participants in this clinical research?
"PsiOxus Therapeutics Ltd are mandated to find 128 eligible participants for this trial. The locations they will be recruiting from include the Washington University Medical School in Saint Louis and MD Anderson in Houston, Texas."
What perils might be associated with utilizing NG-641?
"Due to the fact that this is a Phase 1 clinical trial, our team at Power has rated NG-641's safety as a score of 1 given the scant data verifying its efficacy and safety."
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