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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients must be of non-child-bearing potential or use effective contraception.
Adequate hematologic function, with ANC >1500/µL, Hemoglobin ≥ 9 g/dL, and Platelets ≥ 75,000/µL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a vaccine that produces the full length human HER3 protein to target cancers that express the human epidermal growth factor receptor HER3. The objectives of the study are to determine the safety and tolerability of the vaccine and to see if it can cause a HER3 specific immune response in patients.
Who is the study for?
Adults who've had surgery for solid tumors like breast, lung, or prostate cancer and finished their standard treatments can join. They should be in good physical shape (ECOG 0 or 1), have a life expectancy over 3 months, and normal organ function. Women must not be pregnant and use birth control. People with autoimmune diseases, active infections, brain metastases, or recent other cancers aren't eligible.Check my eligibility
What is being tested?
The trial is testing pING-hHER3FL—a DNA-based vaccine targeting HER3 protein on cancer cells—given as an injection every four weeks for three doses. It aims to see if it's safe and can trigger the immune system to fight cancer expressing the HER3 protein.See study design
What are the potential side effects?
As this is an investigational vaccine, potential side effects are being studied but may include typical vaccine reactions such as pain at the injection site, fatigue, feverish feelings or chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either not able to have children or I use effective birth control.
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My blood counts meet the required levels for treatment.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of T and B cell activity
Secondary outcome measures
Relapse-free survival
Tolerability of pING-hHER3FL
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
4 mg pING-hHER3FL ID or IM
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Who is running the clinical trial?
Herbert LyerlyLead Sponsor
4 Previous Clinical Trials
34 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain.My recent scans show no signs of cancer.I have not taken antibiotics or had an infection in the last 48 hours.I have recovered from side effects of my previous treatments.I've had surgery for cancer, finished chemotherapy, HER2 therapy, and radiation as planned.I have not had cancer other than non-melanoma skin, bladder, or cervical cancer in the past 5 years.I am not on steroids or other immune-suppressing drugs like azathioprine.I can visit the study site for follow-ups as needed.I have an autoimmune disease like lupus or multiple sclerosis.I am either not able to have children or I use effective birth control.My blood counts meet the required levels for treatment.I do not have an active infection, including HIV or hepatitis.I have a type of cancer known to often show HER3 expression.It's been 3 weeks to 2 years since my last cancer treatment.I have received immunotherapy before.My kidney and liver tests are within the required limits.I am fully active or can carry out light work.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Has pING-hHER3FL received authorization from the FDA?
"The safety of pING-hHER3FL is predicted to be low, as this Phase 1 trial only has a limited amount of data supporting its efficacy and safety."
Answered by AI
Is the program actively enrolling new participants?
"The clinical trial, which initiated on the 13th of July 2020 and was last amended November 4th 2022, is currently seeking participants."
Answered by AI
How many individuals are partaking in this experiment?
"Affirmative. The clinicaltrials.gov databank indicates that this research project, which was first uploaded on July 13th 2020, is currently welcoming volunteers. 24 individuals must be enrolled from a single medical facility."
Answered by AI
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