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RECRUITING
NCT05315167
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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