RecruitingPhase 1Phase 2NCT05315167

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

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


Sponsor

Zhuhai Yufan Biotechnologies Co., Ltd

Enrollment

267 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PRJ1-3024 for people with advanced solid malignancies and advanced solid tumor. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRJ1-3024

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

View Full Details on ClinicalTrials.gov

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NCT05315167


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