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Virus Therapy
NG-641 for Advanced Cancer (STAR Trial)
Phase 1
Recruiting
Led By Haesong Park, MD
Research Sponsored by PsiOxus Therapeutics 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 end of study treatment visit
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced epithelial cancers that have failed standard treatments or have no standard options left. Participants must be expected to live at least 6 months, have tumors that can be biopsied safely, and function well in daily life (ECOG status 0-1). They should not have had certain vaccines, major surgeries, or specific treatments recently and must not have active infections or severe autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing NG-641, a new type of therapy designed to target cancer cells selectively. It's the first time this treatment is being used in humans. The main goal is to see how safe it is and how well patients tolerate it when given to those with metastatic or advanced epithelial tumors.See study design
What are the potential side effects?
While the side effects of NG-641 are still being studied as this is its first use in humans, potential risks may include typical reactions related to immune therapies such as inflammation in organs, infusion-related symptoms, fatigue, digestive issues and increased risk of infection.
STAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study treatment visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study treatment visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (safety and tolerability) in study NG-641
STAR Trial Design
1Treatment groups
Experimental Treatment
Group I: IntravenousExperimental Treatment1 Intervention
Phase 1a dose escalation: one cycle of treatment.
Phase 1a dose optimisation: up to 8 cycles of treatment
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Who is running the clinical trial?
PsiOxus Therapeutics LtdLead Sponsor
11 Previous Clinical Trials
604 Total Patients Enrolled
Akamis BioLead Sponsor
11 Previous Clinical Trials
604 Total Patients Enrolled
Haesong Park, MDPrincipal InvestigatorWashington University School of Medicine, St Louis, Missouri
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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