This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors. PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans. This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
PRJ1-3024 is provided as capsules and is administered orally once a day.
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Christ Hospital
Cincinnati, Ohio, United States
NEXT Oncology
Austin, Texas, United States
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Safety listings and pharmacokinetic listings will be used for evaluation
Time frame: Day 1 to Day 21
Incidence of adverse events (AEs)
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
Time frame: 24 months
Pharmacokinetic parameter: Accumulation ratio
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
Time frame: 24 months
Objective response rate (ORR)
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Time frame: 24 months
Duration of response (DOR)
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
Time frame: 24 months
Pharmacokinetic parameter:AUC(0-last)
Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration
Time frame: 24 months
Pharmacokinetic parameter:Maximum observed concentration (Cmax)
assessed as time from time 0 to the time of the last quantifiable concentration
Time frame: 24 months
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Mays Cancer Center
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States