Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05304962
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2022-02-24
Brief Title:
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive HER2-Negative AdvancedMetastatic Breast Cancer
Sponsor:
Regor Pharmaceuticals Inc
Organization:
Regor Pharmaceuticals Inc
Study Overview
Official Title:
First-in-Human Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative AdvancedMetastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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 phase I First-in-Human FIH open-label study to evaluate the safety tolerability pharmacokinetic PK profile and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR HER2- locally advanced and unresectable Stage III or metastatic Stage IV breast cancer whose disease has progressed during prior therapy with an approved CDK46i plus hormonal therapy
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?:
None
Is an FDA AA801 Violation?:
None