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
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT04252768
- Lead Sponsor
- Immutep S.A.S.
- 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 mg/m2 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 mg/m2 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eftilagimod alpha + Paclitaxel Eftilagimod Alpha The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 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 subcutaneosuly as monotherapy. Eftilagimod alpha + Paclitaxel Paclitaxel The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 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 subcutaneosuly as monotherapy.
- Primary Outcome Measures
Name Time Method Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day up to 12 month Severity, frequency and duration of adverse events
- Secondary Outcome Measures
Name Time Method Peripheral IFN-gamma concentration in the blood up to 12 month Changes IFN-gamma concentration in course of treatment with efti
Peripheral IP-10 concentration in the blood up to 12 month Changes IP-10 concentration in course of treatment with efti
AUC of efti given on the same day as paclitaxel up to 12 month AUC after 1st injection of efti
Cmax of efti given on the same day as paclitaxel up to 12 month Cmax after 1st injection of efti
Overall response rate of efti in combination with weekly paclitaxel both given the same day up to 12 month Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Tmax of efti given on the same day as paclitaxel up to 12 month Tmax after 1st injection of efti
Median overall survival of efti in combination with weekly paclitaxel both given the same day up to 20 month The median time frame with overall survival with the use of efti in combination with Paclitaxel
To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day up to 12 month Screen for possible ADA
Median progression free survival of efti in combination with weekly paclitaxel both given the same day up to 20 month The median progression free survival with the use of efti in combination with Paclitaxel