Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06253195
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-02-02
Brief Title:
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HRHER2- 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 Chinese Patients With Advanced or Metastatic HRHER2- Breast Cancer and Other Solid Tumors
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:
None
Brief Summary:
This is an open-label multicenter phase 1a1b clinical study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary antitumor activity of BGB-43395 a cyclin-dependent kinase 4 CDK4 inhibitor as monotherapy or in combination with fulvestrant letrozole or other combination partners in Chinese participants with hormone receptor positive HR and human epidermal growth factor 2 negative HER2- breast cancer BC and other advanced or metastatic solid tumors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CTR20240674 | REGISTRY | ChinaDrugTrials | None |