Recruiting

Phase 1

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

Sponsor:

Peel Therapeutics Inc

Code:

NCT05329103

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PEEL-224

FOLF+B

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Study ID

NCT05329103

Start date

Jul 11, 2022

Status verified date

May, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

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 criteria:

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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A: PEEL-224 Dose Escalation

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.

experimental: Part 1B: PEEL-224 Dose Confirmation

PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A

experimental: Part 2: PEEL-224 plus FOLF+B

PEEL-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.

Interventions

PEEL-224

Lyophilized powder reconstituted with D5W

FOLF+B

infusional 5-FU, LV, and bevacizumab

Primary outcome measure

Determine maximum tolerated dose [ Time Frame: 28 days ]

Central Contacts and Locations

Locations

HonorHealth Research Institiute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Oncology Nurse Navigator

480-323-1364 clinicaltrials@honorhealth.com

Principal Investigator:

Erkut Borazanci, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Stephan Sando

401-606-6602 ssando@brownhealth.org

Principal Investigator:

Howard Safran, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Susan Sharry, CCRP

801-587-4488 susan.sharry@hci.utah.edu

Principal Investigator:

Vaia Florou, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Malaika Komtangi

210-580-9500 mkomtangi@nextoncology.com

Principal Investigator:

Alexander Spira, MD, PhD, FACP

More Information

Sponsor

Peel Therapeutics Inc

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Peel Therapeutics Inc on 2026-05-15.