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Clinical Trial Summary

This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.


Clinical Trial Description

The study was divided into two sections: dose escalation section and expanded enrollment section. In dose escalation section, BPI-16350 were administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors in different dose levels.The study was designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-16350. In expanded enrollment section, based on the results of dose escalation section, BPI-16350 were administered orally to patients with locally advanced or metastatic solid tumors, to further evaluate the safety, tolerability, and pharmacokinetics of BPI-16350. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03791112
Study type Interventional
Source Betta Pharmaceuticals Co., Ltd.
Contact Xichun XI Hu, Ph.D
Phone 13816110335
Email xchu2009@hotmail.com
Status Recruiting
Phase Phase 1
Start date July 18, 2019
Completion date December 31, 2024

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