Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03791112
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-27
First Post:
2018-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor
Sponsor:
Betta Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: