PEEL-224 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PEEL-224 to determine its safety and effectiveness for people with advanced cancers unresponsive to standard treatments. The study begins by identifying the optimal dose of PEEL-224, then tests this dose alone and with other drugs. It seeks participants with advanced or metastatic solid tumors that have worsened after previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, like strong CYP1A2 and CYP3A4 inhibitors or inducers, and systemic corticosteroids, at least 14 days before starting the study. It's best to discuss your current medications with the trial team to see if any need to be stopped.
Is there any evidence suggesting that PEEL-224 is likely to be safe for humans?
Research has shown that PEEL-224 is being tested for safety and tolerance in humans. In other studies, PEEL-224 has been combined with drugs like vincristine and temozolomide, focusing on safety. It's important to note that PEEL-224 is just beginning human trials, so safety information remains limited.
This is a Phase 1 trial, indicating that PEEL-224 is in the early testing stages. The primary goal is to assess its safety for people. This process typically starts with low doses, gradually increasing to determine the safest and most effective amount.
As this is a Phase 1 trial, researchers are still gathering safety data. This stage is crucial for identifying any side effects or unwanted reactions. In early trials, researchers closely monitor participants for any issues. So far, the available data has not reported major safety concerns.
In summary, while PEEL-224 is under safety testing and monitoring, more information will emerge as the trial progresses. Participants receive detailed information about potential risks and benefits to help them make informed decisions.12345Why do researchers think this study treatment might be promising?
Researchers are excited about PEEL-224 for cancer treatment because it offers a different approach compared to standard chemotherapy options. Unlike traditional treatments, which often target rapidly dividing cells in general, PEEL-224 is designed to work by a novel mechanism, potentially offering a more targeted impact on cancer cells while possibly reducing side effects. Additionally, PEEL-224 is administered intravenously in a specific cycle that allows for adaptable dosing, which could lead to better individualized treatment plans. This innovative approach may enhance treatment efficacy and improve patient outcomes.
What evidence suggests that PEEL-224 could be an effective treatment for cancer?
Research has shown that PEEL-224 could be a promising cancer treatment. Studies indicate that when combined with PD-1 inhibitors, PEEL-224 enhances the ability to fight tumors more effectively than when each is used alone. This suggests that PEEL-224 might help the immune system combat tumors. In this trial, researchers are testing PEEL-224 in different contexts: Part 1A involves dose escalation to determine safety and effectiveness for solid tumors, Part 1B confirms the dose, and Part 2 tests PEEL-224 in combination with FOLF+B. Although still in early stages, its mechanism suggests potential benefits for hard-to-treat cancers.12467
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
PEEL-224 is administered intravenously on Days 1, 8, and 15 of a 28-day cycle. Dose escalation will be guided by the mTPI-2 design until a recommended phase 2 dose is determined.
Dose Confirmation
An additional arm of patients will be enrolled to confirm the recommended phase 2 dose.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments every 8 weeks.
What Are the Treatments Tested in This Trial?
Interventions
- PEEL-224
Find a Clinic Near You
Who Is Running the Clinical Trial?
Peel Therapeutics Inc
Lead Sponsor