Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04252768
Status:
WITHDRAWN
Last Update Posted:
2023-03-22
First Post:
2020-01-29
Brief Title:
A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti IMP321 Eftilagimod Alpha as Adjunctive to a Weekly Treatment Regimen of Paclitaxel
Sponsor:
Immutep SAS
Organization:
Immutep SAS
Study Overview
Official Title:
AIPAC-002 Active Immunotherapy PAClitaxel-002 A Multicentre Phase Ib Study to Test a New Schedule of Eftilagimod Alpha a Soluble LAG-3 Protein as Adjunctive to Weekly Paclitaxel in Hormone Receptor-positive Metastatic Breast Carcinoma Patients
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Replaced by other study NCT05747794
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIPAC-002
Brief Summary:
This is a multicentre multinational Phase Ib study in female HR MBC patients not receiving Her2-targeted therapy Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each During each cycle the subject will receive 80 mgm2 paclitaxel intravenously on Day 1 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day 4-week cycle Efti will always be given after paclitaxel The maintenance phase comprises 6 visits with 4 weekly intervals during each such visit 30 mg efti is given subcutaneously as monotherapy A total of 24 subjects will be enrolled into the study The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial
Detailed Description:
This is a multicentre multinational Phase Ib study in female HR MBC patients not receiving Her2-targeted therapy Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each During each cycle the subject will receive 80 mgm2 paclitaxel intravenously on Day 1 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day 4-week cycle Efti will always be given after paclitaxel The maintenance phase comprises 6 visits with 4 weekly intervals during each such visit 30 mg efti is given subcutaneously as monotherapy A total of 24 subjects will be enrolled into the study The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial
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