Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06120283
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-01
Brief Title:
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1a1b Study Investigating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395 Alone or as Part of Combination Therapies in Patients With Metastatic HRHER2- Breast Cancer and Other Advanced Solid Tumors
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:
None
Brief Summary:
This is a dose escalation and dose expansion study to compare how well BGB-43395 a cyclin-dependent kinase 4 CDK4 inhibitor works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive HR and human epidermal growth factor 2 negative HER2- breast cancer BC and other advanced solid tumors The main purpose of this study is to explore the recommended dosing for BGB-43395
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506888-34-00 | REGISTRY | EU CTIS | None |