This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.
This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to ten separate cohorts. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT543.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
232
PRT543 will be administered orally
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
UCSF Precision Cancer Medicine Building
San Francisco, California, United States
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Florida Cancer Specialist
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
...and 13 more locations
To describe dose limiting toxicities (DLT) of PRT543
Dose limiting toxicities (DLTs) will be evaluated during the first cycle
Time frame: Baseline through Day 28.
To determine the maximally tolerated dose (MTD)
The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
Time frame: Baseline through approximately 2 years.
To determine the recommended phase 2 dose (RP2D) and schedule of PRT543
The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
Time frame: Baseline through approximately 2 years.
To describe the adverse event profile and tolerability of PRT543
Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Time frame: Baseline through approximately 2 years
To determine the maximum observed plasma concentration (Cmax) of PRT543
PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration.
Time frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543
PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration
Time frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.