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
No
See if you qualify for this study
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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
Arizona
Scottsdale
California
Palo Alto
North Carolina
Huntersville
Pennsylvania
Philadelphia
Rhode Island
Providence
Texas
Dallas
Utah
Salt Lake City
Virginia
Fairfax
Source: ClinicalTrials.gov · NCT05329103 · last updated 2026-05-15