Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03838367
Status:
UNKNOWN
Last Update Posted:
2022-03-21
First Post:
2019-02-05
Brief Title:
Leronlimab PRO 140 Combined With Carboplatin in Patients With CCR5 mTNBC
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
A Phase IbII Study of Leronlimab PRO 140 Combined With Carboplatin in Patients With CCR5 Metastatic Triple Negative Breast Cancer mTNBC
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 IbII Study of Leronlimab PRO 140 combined with Carboplatin in Patients with CCR5 Metastatic Triple Negative Breast Cancer mTNBC
Study population will consist of patients with CCR5-positive locally advanced or metastatic triple-negative breast cancer mTNBC who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings first-line
Study population will consist of patients with CCR5-positive locally advanced or metastatic triple-negative breast cancer mTNBC who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings first-line
Detailed Description:
Phase Ib
Phase Ib is a dose escalation phase with 3 dose levels cohorts of leronlimab PRO 140 administered in combination with a fixed dose of carboplatin at AUC 5 This dose finding portion of study will follow a 33 designed to determine the maximum tolerated dose MTD of leronlimab PRO 140 administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5
Phase II
Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab PRO 140 SC will increase PFS in patients with CCR5 mTNBC
Phase Ib is a dose escalation phase with 3 dose levels cohorts of leronlimab PRO 140 administered in combination with a fixed dose of carboplatin at AUC 5 This dose finding portion of study will follow a 33 designed to determine the maximum tolerated dose MTD of leronlimab PRO 140 administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5
Phase II
Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab PRO 140 SC will increase PFS in patients with CCR5 mTNBC
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