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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID: NCT05329103
Run by: Peel Therapeutics Inc
People needed: 65
Starts: 2022-07-11
Expected to finish: 2026-10-01
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

NEXT Virginia — Fairfax, Virginia, United States (enrolling)
Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
HonorHealth Research Institiute — Scottsdale, Arizona, United States (enrolling)
Mary Crowley Cancer Research — Dallas, Texas, United States
Stanford Cancer Center — Palo Alto, California, United States
Carolina BioOncology Institute — Huntersville, North Carolina, United States
Abramson Cancer Center at Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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