Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03603951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-29
First Post:
2018-07-10
Brief Title:
A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase 1 Study to Characterize Safety Tolerance Pharmacokinetics and Efficacy of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
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 Phase 1 multicenter single-arm open-label dose escalation and dose expansion study of enhancer of zeste homolog 2 EZH2 inhibitor SHR2554
This study will assess the tolerability safety pharmacokinetics and preliminary anti-tumor activity of SHR2554 in participants with relapsed or refractory mature lymphoid neoplasms in part I and the the efficacy in PTCL patients will be studied in Part II
This study will assess the tolerability safety pharmacokinetics and preliminary anti-tumor activity of SHR2554 in participants with relapsed or refractory mature lymphoid neoplasms in part I and the the efficacy in PTCL patients will be studied in Part II
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None