An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- DrugPEEL-224
Lyophilized powder reconstituted with D5W
- DrugFOLF+B
infusional 5-FU, LV, and bevacizumab
Outcome measures
Primary
Determine maximum tolerated dose
Frequency, severity, and relatedness of dose limiting toxicities
Time frame: 28 days
Secondary
Overall safety and tolerability of PEEL-224
Time frame: through study completion, expected average of 6 months
Antitumor activity assessment
Time frame: every 8 weeks through study completion, expected average of 6 months
Cmax 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 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
Time frame: Through Cycle 1 (28 days)
Eligibility criteria
Study locations (8)
HonorHealth Research Institiute
Scottsdale, Arizona, 85258
Stanford Cancer Center
Palo Alto, California, 94305
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Rhode Island Hospital
Providence, Rhode Island, 02903
Mary Crowley Cancer Research
Dallas, Texas, 75230
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
NEXT Virginia
Fairfax, Virginia, 22031