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.
Title
- 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
P018
- NCT ID:
NCT04252768
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Eftilagimod Alpha | IMP321; efti | Eftilagimod alpha + Paclitaxel |
| Paclitaxel | | Eftilagimod alpha + Paclitaxel |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Eftilagimod alpha + Paclitaxel | Experimental | 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
|
Eligibility Criteria
Inclusion Criteria (selected ones):
- Metastatic oestrogen receptor positive and/or progesterone receptor positive breast
adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a
metastasis
- Subjects who are indicated to receive first line chemotherapy with weekly paclitaxel
- ECOG performance status 0-1
- Expected survival longer than three months
Exclusion Criteria (selected ones):
- Prior chemotherapy for metastatic breast adenocarcinoma
- Disease-free interval of less than twelve months from the last dose of adjuvant
chemotherapy
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue
- Inflammatory carcinoma at time of screening
- Candidate for treatment with trastuzumab (or other Her2/neu targeted agents) or
endocrine based therapy according to the applicable treatment guidelines
- Systemic chemotherapy, radiation therapy or any other investigational agent within 4
weeks, endocrine therapy within 1 week or CDK4/6 inhibitors within 5 times half-life
(acc. to SPC) prior to first dose of study treatment
- Symptomatic known cerebral and/or leptomeningeal metastases
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Severity, frequency and duration of adverse events |
Secondary Outcome Measures
| Measure: | AUC of efti given on the same day as paclitaxel |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | AUC after 1st injection of efti |
| Measure: | Cmax of efti given on the same day as paclitaxel |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Cmax after 1st injection of efti |
| Measure: | Tmax of efti given on the same day as paclitaxel |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Tmax after 1st injection of efti |
| Measure: | Peripheral IFN-gamma concentration in the blood |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Changes IFN-gamma concentration in course of treatment with efti |
| Measure: | Peripheral IP-10 concentration in the blood |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Changes IP-10 concentration in course of treatment with efti |
| Measure: | Overall response rate of efti in combination with weekly paclitaxel both given the same day |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria |
| Measure: | Median progression free survival of efti in combination with weekly paclitaxel both given the same day |
| Time Frame: | up to 20 month |
| Safety Issue: | |
| Description: | The median progression free survival with the use of efti in combination with Paclitaxel |
| Measure: | Median overall survival of efti in combination with weekly paclitaxel both given the same day |
| Time Frame: | up to 20 month |
| Safety Issue: | |
| Description: | The median time frame with overall survival with the use of efti in combination with Paclitaxel |
| Measure: | To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day |
| Time Frame: | up to 12 month |
| Safety Issue: | |
| Description: | Screen for possible ADA |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Immutep S.A.S. |
Last Updated
July 20, 2021
