Actively Recruiting
A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors
Led by Peel Therapeutics Inc · Updated on 2025-06-17
65
Participants Needed
7
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of colorectal cancer confirmed by local pathology review (Part 2 only)
- Have an ECOG performance status of 0 or 1
- Have an advanced or metastatic solid tumor that has progressed after prior standard therapy, are intolerant or ineligible for standard therapy, or have no approved standard therapy
- Have at least one measurable lesion detected by radiological methods as per RECIST v1.1
- Have adequate bone marrow function
- Have adequate liver function
- Have adequate renal function
- Have completed prior anticancer therapy, including investigational agents, at least 28 days or 5 half-lives before study treatment
- Have resolved any significant toxic effects from prior therapy
You will not qualify if you...
- Have primary central nervous system tumors
- Have brain or spinal metastases unless treated and stable without progression or hemorrhage for at least 14 days before first dose
- Have had craniospinal radiotherapy within 12 weeks before first dose
- Have significant serum electrolyte abnormalities
- Received neutrophil growth factor support within 14 days before first dose
- Have an active infection within 14 days before first dose
- Use strong CYP1A2 and CYP3A4 inhibitors or inducers within 14 days before or during the study
- Use systemic corticosteroids within 14 days before first dose
- Are HIV-positive without controlled viral load and adequate CD4 count
- Have uncontrolled hepatitis B or hepatitis C infection
- Are pregnant, lactating, planning pregnancy, or planning to donate gametes during or within 90 days after the study
- Have had another malignancy within 2 years except certain skin and cervical cancers
- Are enrolled in conflicting clinical studies
- Have uncontrolled cardiovascular disease
- History of cerebrovascular accident, transient ischemic attack, or thrombosis requiring treatment within 3 months
- Received or will receive live vaccines within 14 days before first dose
- Tested positive for SARS-CoV-2 infection within 14 days of screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
HonorHealth Research Institiute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
3
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Completed
4
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Completed
5
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Completed
6
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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