Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586866
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-Arm Phase 2 Study to Evaluate the Safety Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study was designed to evaluate the safety efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases
Detailed Description:
This is a multicenter single-arm phase 2 study to evaluate the safety efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases
Patients will receive JK-1201I until disease progression The primary objective of this study is to assess whether treatment with JK-1201I prolongs progression-free Survival PFS according to RECIST 11 and RANO-BM in triple negative breast cancer patients with brain metastases
The secondary objectives of the study are to further evaluate the efficacy safety and pharmacokinetics of JK-1201I
Patients will receive JK-1201I until disease progression The primary objective of this study is to assess whether treatment with JK-1201I prolongs progression-free Survival PFS according to RECIST 11 and RANO-BM in triple negative breast cancer patients with brain metastases
The secondary objectives of the study are to further evaluate the efficacy safety and pharmacokinetics of JK-1201I
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