Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343402
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-22
Brief Title:
Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
Sponsor:
TheRas Inc dba BridgeBio Oncology Therapeutics
Organization:
TheRas Inc dba BridgeBio Oncology Therapeutics
Study Overview
Official Title:
A Phase 1a1b Open-Label Study of BBO-8520 As Monotherapy and As Part of Combination Therapy in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer and Colorectal Cancer - the ONKORAS-101 Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
A first in human study to evaluate the safety tolerability and pharmacokinetics PK of BBO-8520 a KRAS G12C ON inhibitor single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer
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-8520 as a single agent and in combination with pembrolizumab in patients with KRAS Kirsten rat sarcoma G12C mutant non-small cell lung cancer and colorectal cancer The study includes dose escalation phase and dose expansion phase
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ONKORAS-101 | OTHER | TheRas | None |