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Advanced Solid TumorPhase 1NCT05329103

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

A Phase 1 study testing PEEL-224 and FOLF+B in people with Advanced Solid Tumor, run by Peel Therapeutics Inc at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
PEEL-224 and FOLF+B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
8 sitesUnited States
Study dates
11 Jul 2022to Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites, 4 recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Completed

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Malaika Komtangi, 210-580-9500, mkomtangi@nextoncology.com

    Alexander Spira, MD, PhD, FACP

    Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

    Completed

  • Stanford Cancer Center

    Palo Alto, California, 94305

    Active, not recruiting

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

    Completed

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Stephan Sando, 401-606-6602, ssando@brownhealth.org

    Howard Safran, MD

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Susan Sharry, CCRP, 801-587-4488, susan.sharry@hci.utah.edu

    Vaia Florou, MD

    Recruiting

  • HonorHealth Research Institiute

    Scottsdale, Arizona, 85258

    Oncology Nurse Navigator, 480-323-1364, clinicaltrials@honorhealth.com

    Erkut Borazanci, MD

    Recruiting

Other trials in United States

About this study

Official title: An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors

This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors.

Read the detailed description

This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of a novel topoisomerase I inhibitor (PEEL-224) in patients with advanced solid tumors. Dose escalation will be guided by the modified toxicity probability interval-2 (mTPI-2) design with a target toxicity rate of 25% and an acceptable DLT interval of 20% to 30%. Cohorts of 2 or more patients will be sequentially enrolled at progressively higher dose levels of PEEL-224. For each dose level, all patients must complete Cycle 1 before the decision to dose escalate the next cohort of patients is made.

Being tested
PEEL-224, FOLF+B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEL-224Drug

    Lyophilized powder reconstituted with D5W

  • FOLF+BDrug

    infusional 5-FU, LV, and bevacizumab

Study groups in NCT05329103
Study groupRoleWhat they receive
Part 1A: PEEL-224 Dose EscalationExperimentalPEEL-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.
Receives: Drug: PEEL-224
Part 1B: PEEL-224 Dose ConfirmationExperimentalPEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A
Receives: Drug: PEEL-224
Part 2: PEEL-224 plus FOLF+BExperimentalPEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1.
Receives: Drug: PEEL-224; Drug: FOLF+B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine maximum tolerated dose

    Frequency, severity, and relatedness of dose limiting toxicities

    Measured: 28 days

Secondary outcomes (5)

  1. Overall safety and tolerability of PEEL-224

    Frequency, severity, and relatedness of AEs and SAEs

    Measured: through study completion, expected average of 6 months

  2. Antitumor activity assessment

    based on RECIST 1.1

    Measured: every 8 weeks through study completion, expected average of 6 months

  3. Cmax of PEEL-224 and its metabolite

    maximum blood concentration of PEEL-224 and its metabolite

    Measured: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15

  4. Tmax of PEEL-224 and its metabolite

    Time to maximum blood concentration of PEEL-224 and its metabolite

    Measured: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15

  5. changes in QTcF/QTcBBB

    ECG parameter readings

    Measured: Through Cycle 1 (28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start11 Jul 2022
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329103
Sponsor's protocol ID
PEEL-224-001
Status last verified
May 2026
First submitted
31 Mar 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEEL-224 and FOLF+B in people with Advanced Solid Tumor, run by Peel Therapeutics Inc at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine maximum tolerated dose (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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