What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy agents like gemcitabine and nab-paclitaxel, often result in side effects such as neutropenia (low white blood cell count), fatigue, neuropathy (nerve damage), nausea, and diarrhea. These side effects can vary in severity but are frequently observed in patients undergoing such treatments.

What prior FDA approvals exist?

The FDA has approved several antitumor agents for the treatment of solid tumors, focusing on their safety, tolerability, and efficacy. Notable examples include pembrolizumab, an immune checkpoint inhibitor used for various solid tumors, and venetoclax, which is often combined with other agents for enhanced efficacy. These treatments have shown promising antitumor activity and manageable safety profiles, similar to the investigational agent PEEL-224 being studied for advanced solid tumors.

What other types of research exist?

Promising novel alternatives to PEEL-224 for solid tumor patients include immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), targeted therapies (e.g., larotrectinib for NTRK gene fusion-positive tumors, entrectinib), and combination therapies (e.g., atezolizumab with bevacizumab for hepatocellular carcinoma). These treatments have shown significant efficacy in clinical trials and offer new hope for patients with advanced solid tumors.

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PEEL-224 for Cancer

Phase 1

Recruiting

Research Sponsored by Peel Therapeutics Inc

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

Must not have

Primary central nervous system tumors

Active infection ≤14 days prior to the first dose of PEEL-224

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks through study completion, expected average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing PEEL-224, a new drug, in patients with advanced solid tumors. The drug aims to block an enzyme that cancer cells need to grow, potentially slowing down or stopping the 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.

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.

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 below

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I am fully active or can carry out light work.

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My bone marrow is functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer originated in the brain or spinal cord.

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I have not had an infection within the last 14 days.

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I have a serious heart condition that is not under control.

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I have an active hepatitis B or C infection that is not under control.

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I have not taken systemic corticosteroids in the last 14 days.

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I have not had a stroke, mini-stroke, or blood clot treatment in the last 3 months.

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I have not had a live vaccine within 2 weeks before starting PEEL 224.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks through study completion, expected average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine maximum tolerated dose

Secondary study objectives

Antitumor activity assessment

Cmax of PEEL-224 and its metabolite

Overall safety and tolerability of PEEL-224

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. The study of PEEL-224, an antitumor agent, is significant for solid tumor patients as it may offer a novel mechanism of action that could improve efficacy and reduce side effects compared to existing treatments. Understanding these mechanisms helps in tailoring personalized treatment plans and improving patient outcomes.