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Virus Therapy
NG-350A + Pembrolizumab for Advanced Epithelial Cancer (FORTIFY Trial)
Phase 1
Recruiting
Research Sponsored by Akamis Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
At least one measurable site of disease according to RECIST v1.1 criteria; this lesion must be either outside a previously irradiated area or progressive if it is in a previously irradiated area
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days after last dose of study drug
Awards & highlights
FORTIFY Trial Summary
This trial is testing a new drug, NG-350A, in combination with pembrolizumab to treat patients with advanced epithelial tumors.
Who is the study for?
Adults over 18 with advanced epithelial cancer that's relapsed or doesn't respond to standard treatments, or when no standard treatment exists. Participants must have a measurable disease site, be in good physical condition (ECOG 0-1), and have proper organ function. They should not have significant infection risks, bleeding disorders, recent vaccinations, autoimmune diseases requiring recent treatment, certain drug treatments within specific time frames before the trial starts, active brain metastases, or known allergies to study drugs.Check my eligibility
What is being tested?
The FORTIFY trial is testing NG-350A combined with Pembrolizumab on patients with metastatic or advanced epithelial tumors. It's an early-phase study (phase 1a/1b) where all participants receive the experimental therapy without being randomly assigned to different groups.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation of organs and infusion-related reactions. There may also be fatigue, increased risk of infections due to immunosuppression from Pembrolizumab and potential tissue damage at tumor sites.
FORTIFY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have at least one tumor that can be measured and has not been treated with radiation, or it has grown despite radiation.
Select...
My tumor can be safely biopsied, and I agree to have it done.
Select...
My cancer has returned or didn't respond to treatment, and there's no standard treatment left.
Select...
My liver is working well.
FORTIFY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days after last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days after last dose of study drug
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)
FORTIFY Trial Design
1Treatment groups
Experimental Treatment
Group I: All cohortsExperimental Treatment1 Intervention
NG-350A and pembrolizumab
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Who is running the clinical trial?
Akamis BioLead Sponsor
11 Previous Clinical Trials
592 Total Patients Enrolled
PsiOxus Therapeutics LtdLead Sponsor
11 Previous Clinical Trials
592 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,473 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have had or am planning to have a bone marrow or organ transplant.My lungs are functioning well enough for treatment.I have used specific treatments before.I do not have any ongoing infections needing strong medication or hospital care.I have at least one tumor that can be measured and has not been treated with radiation, or it has grown despite radiation.My tumor can be safely biopsied, and I agree to have it done.My cancer has returned or didn't respond to treatment, and there's no standard treatment left.I have taken antiviral medication recently.I am 18 years old or older.My cancer is in a specific location or has spread to a certain extent.I have a history of kidney problems.My immune system may be weakened due to certain medical conditions or treatments.My liver is working well.I have had radiation pneumonitis in the past.I have not had any other cancer in the last 3 years.I have had my spleen removed.My blood cell counts are within a healthy range.My kidneys are working well.I have a history of serious heart, blood vessel, or clotting problems.I have a history of lung conditions.I have active brain metastases or cancer in the lining of my brain.I have a history of hepatitis B, active hepatitis C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: All cohorts
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process still active for this medical experiment?
"According to the clinicaltrials.gov listing, this medical trial is presently seeking participants and was first made available on April 13th 2022. The information has been most recently updated on October 6th of the same year."
Answered by AI
Could you explain the therapeutic function of NG-350A in combination with Pembrolizumab?
"NG-350A in combination with Pembrolizumab can be used to combat malignant neoplasms, unresectable melanoma and cases of microsatellite instability high."
Answered by AI
Are there any records of prior experiments using NG-350A in conjunction with Pembrolizumab?
"NG-350A in combination with Pembrolizumab was first studied at City of Hope a decade ago, and since then 249 studies have been completed. At present, there are 963 active trials being conducted throughout the United States - many of them taking place in Houston, Texas."
Answered by AI
Has the NG-350A and Pembrolizumab combination been validated by the FDA?
"Due to the small amount of clinical data supporting its safety and efficacy, our team ranks NG-350A plus Pembrolizumab with a score of 1."
Answered by AI
How many participants have signed up for this investigation?
"Confirmed. According to clinicaltrials.gov, registration for this medical trial is ongoing since its first listing on April 13th 2022 and most recent update on October 6th 2022. The study requires 198 participants across 2 sites."
Answered by AI
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