Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06224387
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-05-07
Brief Title:
CTS2190 Phase I II Clinical Study in Patients
Sponsor:
CytosinLab Therapeutics Co Ltd
Organization:
CytosinLab Therapeutics Co Ltd
Study Overview
Official Title:
A Multi-center Open-label Dose EscalationExpansion Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Anti-tumor Activity of CTS2190 in Patients With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This is a first in human study in patients with advanced or metastatic solid tumors The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific tumor types The study drug CTS2190 is a PRMT1 inhibitor administered orally The study is planned to treat up to 224 participants
Detailed Description:
This is a Phase 12 multi-center open label study in solid tumor patients Phase 1Part1 is a dose escalation study of oral CTS2190 in patients with solid tumorswhich is planned to treat up to 144 participants
Phase 2Part2 is an open label dose expansion study in specific tumor types In both parts of the study participants who tolerate the drug may continue the treatment until disease progression
The study duration for each subject is defined as beginning from 28 days prior to the first dose until the subject withdrawal of informed consent end of treatment loss to follow-up or death completes 48 weeks of continuous treatment or the study ends early whichever occurs first The end of study is defined as the date when the last subject completes the last visit specified in the protocol
Phase 2Part2 is an open label dose expansion study in specific tumor types In both parts of the study participants who tolerate the drug may continue the treatment until disease progression
The study duration for each subject is defined as beginning from 28 days prior to the first dose until the subject withdrawal of informed consent end of treatment loss to follow-up or death completes 48 weeks of continuous treatment or the study ends early whichever occurs first The end of study is defined as the date when the last subject completes the last visit specified in the protocol
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