Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05827614
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-03-27
Brief Title:
Study of the CHK1 Inhibitor BBI-355 an EcDNA-directed Therapy ecDTx in Subjects with Tumors with Oncogene Amplifications
Sponsor:
Boundless Bio
Organization:
Boundless Bio
Study Overview
Official Title:
An Open-Label Multicenter First-in-Human Dose-Escalation and Dose-Expansion Phase 12 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications
Status:
RECRUITING
Status Verified Date:
2024-10
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:
POTENTIATE
Brief Summary:
BBI-355 is an oral potent selective checkpoint kinase 1 or CHK1 small molecule inhibitor in development as an ecDNA extrachromosomal DNA directed therapy ecDTx This is a first-in-human open-label 3-part Phase 12 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies
Detailed Description:
BBI-355 is administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists
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