A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
PRJ1-3024: PRJ1-3024 is provided as capsules and is administered orally once a day.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period — Day 1 to Day 21
Safety listings and pharmacokinetic listings will be used for evaluation
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| The first affiliated hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| West China Hospital of Sichuan University | Chengdu | Sichuan | Recruiting |
| Cancer hospital of the University of Chinese Academy of Sciences | Hangzhou | Zhejiang | Recruiting |
| Beijing Cancer Hospital | Beijing | China | Recruiting |
| The Fifth Medical Center of PLA General Hospital | Beijing | China | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05315167 on ClinicalTrials.gov ↗ ← All trials in China