This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.
Using dose escalation, 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. Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors. This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
267
PRJ1-3024 is provided as capsules and is administered orally once a day.
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGCancer hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
RECRUITINGThe Fifth Medical Center of PLA General Hospital
Beijing, China
RECRUITINGIncidence 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#AUC0-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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