Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625775
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Dose Escalation and Expansion of BBO-10203 in Advanced Solid Tumors BREAKER-101
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1a1b Study of the PI3KαRAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors The BREAKER-101 Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
First in human study to evaluate the safety tolerability and pharmacokinetics PK of BBO-10203 a PI3KαRAS breaker alone and in combination with trastuzumab in patients with advanced solid tumors
Detailed Description:
This is an open-label multi-center Phase 1a1b study designed to evaluate the safety tolerability preliminary antitumor activity and PK of BBO-10203 as a single agent and in combination with trastuzumab in patients with locally advanced unresectable or metastatic ie advanced solid tumors The study includes a dose escalation phase and an expansion phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None