Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05463263
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2022-06-30
Brief Title:
A Phase 12 Study of STP938 for Adult Subjects With RelapsedRefractory B-Cell and T-Cell Lymphomas
Sponsor:
Step Pharma SAS
Organization:
Step Pharma SAS
Study Overview
Official Title:
An Open-Label First in Human Phase 12 to Evaluate Safety Tolerability Pharmacokinetics and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With RelapsedRefractory B-Cell and T-Cell Lymphomas
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The Phase 1 part of the study is a dose escalation of STP938 as monotherapy
The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas
The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas
Detailed Description:
The drug STP938 is an inhibitor of an enzyme called cytidine triphosphate synthase 1 CTPS1 CTPS1 and a very similar enzyme cytidine triphosphate synthase 2 CTPS2 control the final step in the production of the cytidine triphosphate CTP CTP is an essential building block of deoxyribonucleic acid DNA and ribonucleic acid RNA Studies of people with inherited mutations of the CTPS1 gene indicate that certain types of blood cells required CTPS1 in order to divide rapidly whereas other cells in the body use the CTPS2 enzyme Based on these observations it is expected that blocking CTPS1 using the drug STP938 may be an effective treatment for certain types of cancer that arise from blood cells
The purpose of this study is to see if STP938 is effective at treating different types of lymphoma STP938 will be given as a tablet Blood samples will be taken during the study in order to understand the effects of STP938 on the lymphoma and on the rest of the body The main outcome of the first part of the study is to see if STP938 can be given safely to patients with lymphoma and to work out the best dose of STP938 The main outcome of the second part of the study is to see if ST938 is effective in treating different types of lymphoma
The purpose of this study is to see if STP938 is effective at treating different types of lymphoma STP938 will be given as a tablet Blood samples will be taken during the study in order to understand the effects of STP938 on the lymphoma and on the rest of the body The main outcome of the first part of the study is to see if STP938 can be given safely to patients with lymphoma and to work out the best dose of STP938 The main outcome of the second part of the study is to see if ST938 is effective in treating different types of lymphoma
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