Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299761
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-02-26
Brief Title:
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene 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-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications
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:
STARMAP
Brief Summary:
BBI-825 is a potent selective oral small molecule inhibitor of ribonucleotide reductase RNR This is a first-in-human open-label non-randomized 3-part Phase 12 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies
Detailed Description:
BBI-825 will be administered orally PO twice daily BID to subjects with locally advanced or metastatic non-resectable solid tumors 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