Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734262
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-01-29
Brief Title:
A Phase II Study to Explore the Safety Tolerability and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer TNBC
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Study to Explore the Safety Tolerability and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer TNBC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
SPARK
Brief Summary:
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer TNBC patients
Detailed Description:
This is a prospective single-center three cohorts phase II clinical trial in locally recurrent or metastatic triple-negative breast cancerTNBC patients Subjects will be divided into three cohorts by different treatment combination Cohort A Cohort B aim to explore the two dosages of sitravatinib in combination with tislelizumab in TNBC with prior 3 treatment line Cohort A patients will receive 70mg sitravatinib QD PO in combination with 200mg tislelizumab Q3W IV Cohort B patients will receive 100mg sitravatinib QD PO in combination with 200mg tislelizumab Q3W IV Cohort C aims to explore the sitravatinib QD PO plus 200mg tislelizumab Q3W IV and 100 mgm2 nab-paclitaxel D1 D8 Q3W IV in TNBC previously untreated for metastatic setting or recurredmetastasized after surgery Subjects in the three cohorts will be treated until disease progression intolerable toxicity informed consent withdrawn or investigators-determined medication termination Drug efficacy and safety data will be collected
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