NCT03791112

A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Cancer

Interventions

Type	Name	Description
DRUG	BPI-16350	BPI-16350 capsules administered orally

Timeline

• Start date: 2019-07-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-01-02
• Last updated: 2025-01-27

Locations

1 site across 1 country: China