Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386705
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
TSN084 Treating 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:
RECRUITING
Status Verified Date:
2024-07
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 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 phase 1a1b 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 in China
Detailed Description:
The phase 1a part will begin with an exploration of TSN084 dose and regimen to determine the maximum tolerated dose MTD andor recommended dose for further investigation ie RP2D In Phase 1b part separate cohorts of patients with different histological diagnosis will be evaluated for the clinical activity and efficacy of TSN084 at the recommended dose
Study Oversight
Has Oversight DMC:
None
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?:
None