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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG of 0 or 1
Adequate bone marrow reserve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks through study completion, expected average of 6 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works against cancer.
Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after standard treatments, or when no standard care exists. Participants must be in good physical condition (ECOG 0 or 1), have measurable tumors, and proper organ function. They can't join if they've used certain drugs recently, have uncontrolled diseases, other cancers within the last 2 years, brain metastases unless treated and stable, are pregnant/breastfeeding, or plan to donate gametes.Check my eligibility
What is being tested?
The study tests PEEL-224's safety and effectiveness in treating advanced solid tumors. It's a first-in-human trial where doses will gradually increase to find the right balance between safety and response. The drug's behavior in the body (pharmacokinetics) and its impact on tumor size will also be assessed.See study design
What are the potential side effects?
Since this is a first-in-human study of PEEL-224, specific side effects aren't yet known but may include typical reactions seen with cancer therapies such as nausea, fatigue, allergic reactions or changes in blood counts which could lead to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My bone marrow is functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks through study completion, expected average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks through study completion, expected average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine maximum tolerated dose
Secondary outcome measures
Antitumor activity assessment
Cmax of PEEL-224 and its metabolite
Overall safety and tolerability of PEEL-224
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PEEL-224 Dose EscalationExperimental Treatment1 Intervention
PEEL-224 is administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. The study will begin at a low starting dose and will increase between cohorts according to mTPI-2 until a recommended phase 2 dose is determined. Approximately 10 dose levels are anticipated to be studied.
Group II: PEEL-224 Dose ConfirmationExperimental Treatment1 Intervention
An additional arm of patients will be enrolled after dose escalation is completed to confirm the recommended phase 2 dose.
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Who is running the clinical trial?
Peel Therapeutics IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong drugs that affect liver enzymes in the last 14 days.My brain or spinal cancer has been treated and hasn't worsened or bled in the last 14 days.My liver is working well.I am fully active or can carry out light work.I am HIV-positive with a CD4 count ≥ 300, undetectable viral load, and on anti-retroviral therapy.My cancer originated in the brain or spinal cord.My kidneys are working well.I have not had an infection within the last 14 days.I have a serious heart condition that is not under control.I have an active hepatitis B or C infection that is not under control.I finished my last cancer treatment at least 28 days ago or 5 half-lives ago, whichever is shorter.I received a treatment to boost my white blood cells less than 14 days before starting PEEL 224.I have not taken systemic corticosteroids in the last 14 days.I have not had a stroke, mini-stroke, or blood clot treatment in the last 3 months.I have not had a live vaccine within 2 weeks before starting PEEL 224.I have not had any other cancer except for non-melanoma skin cancer or cervical cancer in situ in the last 2 years.I am not pregnant, breastfeeding, planning to become pregnant, or donate eggs/sperm during or 90 days after the study.My advanced cancer has not responded to standard treatments, or I can't receive them.I have recovered from serious side effects of my previous treatments.My bone marrow is functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: PEEL-224 Dose Escalation
- Group 2: PEEL-224 Dose Confirmation
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.
Are there multiple centers managing this trial?
"Patients are able to enrol in the trial at Mary Crowley Cancer Research (Dallas, Texas), HonorHealth Research Institute (Scottsdale, Arizona) and Abramson Cancer Center at Pennsylvania Hospital (Philadelphia, Pennsylvania). Additionally, there are 3 other locations available."
Answered by AI
Are there any potential side-effects related to the use of PEEL-224?
"Limited data regarding the efficacy and safety of PEEL-224 caused it to receive a score of 1 on our team's scale."
Answered by AI
How many individuals are being recruited for this clinical investigation?
"Peel Therapeutics Inc. will be overseeing this clinical trial, which necessitates the enrolment of 42 eligible participants from Mary Crowley Cancer Research (Dallas, TX) and HonorHealth Research Institute (Scottsdale, AZ)."
Answered by AI
Is it possible to enroll in this experiment presently?
"According to the clinicaltrials.gov listing, this trial is currently recruiting patients. It was first published on July 11th 2022 and details were most recently revised on October 19th of that same year."
Answered by AI
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