Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530810
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia CML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Open-label Multi-center Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of HS-10382 Combination Therapy in Patients With Chronic Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HS-10382 is a small molecular oral potent allosteric inhibitor By binding a myristoyl site of the BCR-ABL1 protein HS-10382 locks BCR-ABL1 into an inactive conformation Flumatinib is the first approved second generation TKI in China and a derivative of imatinib
The primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia CML
The secondary objectives is to evaluate the PK profile major metabolites and efficacy of HS-10382 in CML-CPAP subjects after combination therapy and to explore the kinase domain mutations associated with TKI resistance
The primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia CML
The secondary objectives is to evaluate the PK profile major metabolites and efficacy of HS-10382 in CML-CPAP subjects after combination therapy and to explore the kinase domain mutations associated with TKI resistance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None