Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd
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.
Official title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
267
Start Date
2022-05-30
Completion Date
2027-11-15
Last Updated
2024-12-17
Healthy Volunteers
No
Interventions
PRJ1-3024
PRJ1-3024 is provided as capsules and is administered orally once a day.
Locations (5)
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Cancer hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China
The Fifth Medical Center of PLA General Hospital
Beijing, China