A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors
- Registration Number
- NCT05329103
- Lead Sponsor
- Peel Therapeutics Inc
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A: PEEL-224 Dose Escalation PEEL-224 PEEL-224 is administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. The study will begin at a low starting dose and will increase between cohorts according to mTPI-2 until a recommended phase 2 dose is determined. Approximately 10 dose levels are anticipated to be studied. Part 1B: PEEL-224 Dose Confirmation PEEL-224 PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A Part 2: PEEL-224 plus FOLF+B PEEL-224 PEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1. Part 2: PEEL-224 plus FOLF+B FOLF+B PEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1.
- Primary Outcome Measures
Name Time Method Determine maximum tolerated dose 28 days Frequency, severity, and relatedness of dose limiting toxicities
- Secondary Outcome Measures
Name Time Method changes in QTcF/QTcBBB Through Cycle 1 (28 days) ECG parameter readings
Cmax of PEEL-224 and its metabolite Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15 maximum blood concentration of PEEL-224 and its metabolite
Overall safety and tolerability of PEEL-224 through study completion, expected average of 6 months Frequency, severity, and relatedness of AEs and SAEs
Antitumor activity assessment every 8 weeks through study completion, expected average of 6 months based on RECIST 1.1
Tmax of PEEL-224 and its metabolite Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15 Time to maximum blood concentration of PEEL-224 and its metabolite
Trial Locations
- Locations (7)
HonorHealth Research Institiute
🇺🇸Scottsdale, Arizona, United States
Stanford Cancer Center
🇺🇸Palo Alto, California, United States
Carolina BioOncology Institute
🇺🇸Huntersville, North Carolina, United States
Abramson Cancer Center at Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
HonorHealth Research Institiute🇺🇸Scottsdale, Arizona, United States