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A Study of PEEL-224 for Advanced Solid Tumors

This study is testing a new drug called PEEL-224 in people with advanced solid tumors. It's designed to find the highest safe dose of PEEL-224 and see if it has any anti-tumor activity. You might be able to join if you are 18 or older, have an advanced or metastatic (spread to other parts of the body) solid tumor that has progressed after other treatments, or if standard treatments aren't an option for you. For some parts of the study, you'll need to have colorectal cancer. The main goal is to find the maximum tolerated dose (MTD) of PEEL-224 within 28 days. The study is currently enrolling about 65 participants.

Study design
This is a first-in-human, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will enroll about 65 participants to test increasing doses of PEEL-224.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to determine the maximum tolerated dose within 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05329103

A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Peel Therapeutics Inc
~65 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:PEEL-224FOLF+B

At a glance

Recruiting sites
4 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine maximum tolerated dose
Measured over 28 days

Conditions

Advanced Solid Tumor

Explore related trials

Colorectal CarcinomaSolid Neoplasm

Where it's being run

8 sites across 8 states
Arizona1
California1
North Carolina1
Pennsylvania1
Rhode Island1
Texas1
Utah1
Virginia1

Who to contact

Oncology Nurse Navigator
[email protected]
480-323-1364
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Have a diagnosis of colorectal cancer confirmed by local pathology review (histology or cytology) - Part 2 only
ECOG of 0 or 1
Have a diagnosis of advanced or metastatic solid tumor that has progressed after prior standard therapy, have been intolerant or ineligible for standard therapy, or have a malignancy for which there is no approved therapy considered standard of care
Have at least 1 documented measurable lesion as detected by radiological methods at study entry as per Response Evaluation Criteria in Solid Tumors v1.1
Have adequate bone marrow reserve
Have adequate liver function
Have adequate renal function
Have completed prior anticancer therapy, including investigational agents, ≥28 days or 5 half lives, whichever is shorter, prior to study treatment
Have resolution of any clinically significant toxic effects of prior therapy

Exclusion

Have primary central nervous system tumors
Have brain or spinal metastases, except if treated by surgery, surgery plus focal radiotherapy, or radiotherapy alone, with no evidence of progression or hemorrhage ≤14 days prior to the first dose of PEEL-224. Have craniospinal radiotherapy ≤12 weeks prior to the first dose of PEEL-224
Have significant abnormalities in the level of serum electrolytes
Have received neutrophil growth factor support ≤14 days prior to the first dose of PEEL 224
Have an active infection ≤14 days prior to the first dose of PEEL-224
Use of strong cytochrome P450 (CYP)1A2 and CYP3A4 inhibitors and/or inducers ≤14 days prior to the first dose of PEEL-224 or during the study
Use of systemic corticosteroids ≤14 days prior to the first dose of PEEL-224
Are known to be HIV-positive, unless CD4 + lymphocyte count ≥ 300/μL, undetectable viral load; AND Receiving anti-retroviral therapy.
Have uncontrolled hepatitis B infection or hepatitis C infection;
Are pregnant or lactating, plan to become pregnant, or plan to donate gametes (ova or sperm) for in vitro fertilization during the study period or for 90 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy does not occur during the study will be excluded;
Have evidence of another malignancy ≤2 years prior to screening (except in situ non melanoma skin cell cancers and in situ cervical carcinoma);
Are currently enrolled in another therapeutic clinical study or a non-therapeutic clinical study that will conflict with scheduled visits required by this study;
Have clinically significant, uncontrolled cardiovascular disease
Have history of cerebrovascular accident, transient ischemic attack, or thrombosis requiring treatment ≤3 months prior to the first dose of PEEL-224
Have received or will receive a live vaccine ≤14 days prior to the first dose of PEEL 224.
Have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤14 days of the Screening Visit.

What this trial measures

  • Determine maximum tolerated dose28 days

    Frequency, severity, and relatedness of dose limiting toxicities