An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors
Peel Therapeutics Inc
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.
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 d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Have a diagnosis of colorectal cancer confirmed by local pathology review (histology or cytology) - Part 2 only * ECOG of 0 or 1 * Have a diagnosis of advanced or metastatic solid tumor that has progressed after prior standard therapy, have been intolerant or ineligible for standard therapy, or have a malignancy for which there is no approved therapy considered standard of care * Have at least 1 documented measurable lesion as detected by radiological methods at study entry as per Response Evaluation Criteria in Solid Tumors v1.1 * Have adequate bone marrow reserve * Hav…
Interventions
- DrugPEEL-224
Lyophilized powder reconstituted with D5W
- DrugFOLF+B
infusional 5-FU, LV, and bevacizumab
Locations (7)
- HonorHealth Research InstitiuteScottsdale, Arizona
- Stanford Cancer CenterPalo Alto, California
- Carolina BioOncology InstituteHuntersville, North Carolina
- Abramson Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania
- Mary Crowley Cancer ResearchDallas, Texas
- Huntsman Cancer Institute, University of UtahSalt Lake City, Utah