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.
This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of a novel topoisomerase I inhibitor (PEEL-224) in patients with advanced solid tumors. Dose escalation will be guided by the modified toxicity probability interval-2 (mTPI-2) design with a target toxicity rate of 25% and an acceptable DLT interval of 20% to 30%. Cohorts of 2 or more patients will be sequentially enrolled at progressively higher dose levels of PEEL-224. For each dose level, all patients must complete Cycle 1 before the decision to dose escalate the next cohort of patients is made.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
HonorHealth Research Institiute
Scottsdale, Arizona, United States
RECRUITINGStanford Cancer Center
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGCarolina BioOncology Institute
Huntersville, North Carolina, United States
Determine maximum tolerated dose
Frequency, severity, and relatedness of dose limiting toxicities
Time frame: 28 days
Overall safety and tolerability of PEEL-224
Frequency, severity, and relatedness of AEs and SAEs
Time frame: through study completion, expected average of 6 months
Antitumor activity assessment
based on RECIST 1.1
Time frame: every 8 weeks through study completion, expected average of 6 months
Cmax of PEEL-224 and its metabolite
maximum blood concentration of PEEL-224 and its metabolite
Time frame: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15
Tmax of PEEL-224 and its metabolite
Time to maximum blood concentration of PEEL-224 and its metabolite
Time frame: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15
changes in QTcF/QTcBBB
ECG parameter readings
Time frame: Through Cycle 1 (28 days)
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Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
COMPLETEDRhode Island Hospital
Providence, Rhode Island, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
COMPLETEDHuntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITING