This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.
This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
PRT1419 will be administered by intravenous infusion
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dose limiting toxicities (DLT) of PRT1419
Dose limiting toxicities will be evaluated through the first cycle
Time frame: Baseline through Day 28
Maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors.
Time frame: Baseline through approximately 2 years
Recommended phase 2 dose (RP2D) and schedule of PRT1419
The RP2D will be established for further investigation in participants with advanced solid tumors.
Time frame: Baseline through approximately 2 years
Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments
Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT1419: maximum observed plasma concentration
PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration
Time frame: Baseline through approximately 2 years
Anti-tumor activity of PRT1419: measurement of objective responses
Anti-tumor activity of PRT1419 will be based on the measurement of objective responses
Time frame: Baseline through approximately 2 years
Progression-free survival
Progression-free survival will be calculated from the first administration of PRT1419 until death or until the criteria for disease progression are met
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Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Time frame: Baseline through approximately 2 years