RecruitingAdvanced Solid Tumor

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

Eligible age

18+ yrs

Accepts

All genders

Locations

8 states

Healthy volunteers

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About this study

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.

Sponsor: Peel Therapeutics Inc

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

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.

Where it's recruiting

Scottsdale

Palo Alto

Huntersville

Philadelphia

Providence

Dallas

Salt Lake City

Fairfax

Source: ClinicalTrials.gov · NCT05329103 · last updated 2026-05-15