Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05300438
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-03-08
Brief Title:
Phase I Study of TSN084 in Patients With Advanced Malignant Tumors
Sponsor:
Tyligand Bioscience Shanghai Limited
Organization:
Tyligand Bioscience Shanghai Limited
Study Overview
Official Title:
A Multicenter Open-label Phase IaIb Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
TSN084 is a novel type II protein kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases such as c-MET FLT3 TRK and serinethreonine kinase CDK819 This first-in-human study is conducted to assess the maximum tolerated dose MTD and dose-limiting toxicity DLT to evaluate the pharmacokinetics safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies
Detailed Description:
None
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