Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515470
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Safety Tolerability Pharmacokinetics and Preliminary Efficacy of BTX-9341 in Advanced andor Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-Human Open-Label Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced andor Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant a currently marketed medication for breast cancer in participants with advanced andor metastatic hormone receptor positive HRhuman epidermal growth factor receptor 2 negative HER2- breast cancer The study includes a dose escalation part Part A where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 fulvestrant followed by a dose expansion part Part B where participants will receive the dose of BTX-9341 selected in Part A fulvestrant
Detailed Description:
This first-in-human FIH Phase 1 study of BTX-9341 is multicenter nonrandomized and open-label to evaluate the safety tolerability pharmacokinetics PK and preliminary efficacy of BTX-9341 in participants with advanced andor metastatic HRHER2 breast cancer The study will include a dose escalation part Part A followed by a dose expansion part Part B During Part A BTX-9341 will initially be dose escalated alone and then in combination with fulvestrant A single combination therapy cohort of BTX-9341 fulvestrant will be further explored in Part B BTX-9341 will be administered orally in 28-day treatment cycles
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