Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05504213
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2022-05-17
Brief Title:
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase Ib Open-label Multicenter Study to Evaluate Safety Tolerability Pharmacokinetics and Efficacy of HS-10352 in Combination With Fulvestrant in Patients With Hormone Receptor HR Positive Human Epidermal Growth Factor 2 HER2-Negative PIK3CA Mutation Locally Advanced or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2022-05
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:
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase p110α The purpose of this study is to assess the safety tolerability pharmacokinetics PK and efficacy of HS-10352 plus fulvestrant in patients with hormone receptor HR positive human epidermal growth factor 2 HER2-negative advanced breast cancer ABC harboring PIK3CA mutations
Detailed Description:
This is a Phase Ib open-label 2-Part multi-center study in China The study will be conducted in two stages Stage 1 is the dose-escalation part which is designed to evaluate the safety tolerability PK and efficacy as well as to determine the maximum tolerable dosage MTD or maximum applicable dose MAD of HS-10352 in combination with fulvestrant Stage 2 is the dose-expansion part which is aimed to further assess the efficacy safety tolerability and PK and to establish the recommended phase 2 dose RP2D of HS-10352 in combination with fulvestrant
All participants will be carefully monitored for adverse events AE during the study treatment and for 28 days after the last dose of study drug The PK characteristics of HS-10352 and fulvestrant will be evaluated from C1 to C6 Subjects of this study will be assessed for progression once every 8 weeks until objective disease progression or withdrawal from the trial As the disease progresses survival follow-up is recommended bimonthly
All participants will be carefully monitored for adverse events AE during the study treatment and for 28 days after the last dose of study drug The PK characteristics of HS-10352 and fulvestrant will be evaluated from C1 to C6 Subjects of this study will be assessed for progression once every 8 weeks until objective disease progression or withdrawal from the trial As the disease progresses survival follow-up is recommended bimonthly
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