Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565275
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2020-09-01
Brief Title:
A Study of ICP-192 in Patients With Advanced Solid Tumors
Sponsor:
Beijing InnoCare Pharma Tech Co Ltd
Organization:
Beijing InnoCare Pharma Tech Co Ltd
Study Overview
Official Title:
A Multi-center Open-label Phase III Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations
Status:
RECRUITING
Status Verified Date:
2023-03
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 is a multi-center open-label phase III clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations It consists of two parts Part I Phase I dose escalation and Part II Phase II dose expansion
Detailed Description:
Part I Phase I of the study enrolls patients with advanced solid tumors 9-15 patients Part II Phase II of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations 30 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None