An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- FOLF+B
- Conditions
- Advanced Solid Tumor
- Sponsor
- Peel Therapeutics Inc
- Enrollment
- 65
- Locations
- 7
- Primary Endpoint
- Determine maximum tolerated dose
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 2: PEEL-224 plus 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.
Intervention: FOLF+B
Part 1A: PEEL-224 Dose Escalation
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.
Intervention: PEEL-224
Part 1B: PEEL-224 Dose Confirmation
PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A
Intervention: PEEL-224
Part 2: PEEL-224 plus 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.
Intervention: PEEL-224
Outcomes
Primary Outcomes
Determine maximum tolerated dose
Time Frame: 28 days
Frequency, severity, and relatedness of dose limiting toxicities
Secondary Outcomes
- 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)
- Overall safety and tolerability of PEEL-224(through study completion, expected average of 6 months)
- Antitumor activity assessment(every 8 weeks through study completion, expected average of 6 months)
- 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)
- changes in QTcF/QTcBBB(Through Cycle 1 (28 days))