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ENB003 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new cancer drug, ENB003, to see if it is safe and effective. The study will first test the drug on a small group of people to see what doses are safe. Then the study will be expanded to include more people with different types of cancer.
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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
Media Library
- I stopped a cancer immunotherapy due to a severe side effect.My pancreatic cancer has worsened despite treatment with FOLFIRINOX or a gemcitabine-based regimen.My head or neck cancer worsened despite treatment with an anti-PD1/L1 drug.My breast cancer is triple negative and has spread.My melanoma cannot be removed by surgery and has spread.My breast cancer is triple negative and has been tested for PD-L1.My pancreatic cancer is advanced, cannot be surgically removed, or has come back after surgery.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have ovarian cancer and have had up to 3 treatments for it.My cancer is a type of skin cancer that has spread from my head or neck.My ovarian cancer did not respond to initial platinum-based chemotherapy.I have a confirmed diagnosis of advanced ovarian, fallopian tube, or peritoneal cancer.I have had at most 2 treatments for my advanced pancreatic cancer.My melanoma got worse despite treatment with an anti-PD1/L1 drug.My condition worsened after treatment, and I've had 3 or fewer prior treatments.I have had 3 or fewer treatments for advanced melanoma.Your heart's electrical activity, measured by ECG, shows a longer than normal QT interval.You have cancer that has spread to your brain or the covering of your brain.You have had a tissue or organ transplant from another person.
- Group 1: ENB003 150 ug + Pembrolizumab
- Group 2: ENB003 300 ug + Pembrolizumab
- Group 3: ENB003 500 ug + Pembrolizumab
- Group 4: ENB003 750 ug + Pembrolizumab
- Group 5: ENB003 1000 ug + Pembrolizumab
- Group 6: ENB003 2000 ug + Pembrolizumab
- Group 7: ENB003 RP2D from dose escalation + Pembrolizumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What are the main goals of this medical study?
"The primary efficacy outcome of this study will be measured by ORR, and time frame for evaluation is up to 2 years. Secondary outcomes include the pharmacokinetic parameters Cmax, AUC, and Tmax which will be measured through blood samples over an 8 hour period."
Might I be a candidate for this clinical research?
"This clinical trial is recruiting 130 participants, between the ages of 18 and 80 who have malignancies. It is important that participants also meet the following criteria: -Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma., -Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST Version 1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression.1, -If subjects have high micro"
Are people currently signing up to participate in this research?
"The study is currently recruiting patients, according to the clinicaltrials.gov website. The trial was originally posted on February 18th, 2020 and last updated March 4th, 2021."
What are the most similar previous medical studies to this one involving Pembrolizumab?
"Pembrolizumab is being trialed in 1000 ongoing studies, 122 of which are in Phase 3. The global clinical trial landscape for Pembrolizumab is largely located in Houston, Texas; however, there are 36030 locations running trials for this medication."
If an individual is over 18 years old, do they qualify to participate in this particular medical study?
"According to the information available, this trial is only open to applicants between 18-80 years old. Out of the 4,126 similar studies found, 206 were for patients under 18 and 3,526 were for people over 65."
What is the total sample size for this research project?
"That is correct. The clinical trial, which was originally posted on February 18th 2020 and updated on March 4th 2021, is still recruiting patients. They have 1 site and are looking for 130 individuals in total."
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