Clinical trial NCT04252768: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: Immutep S.A.S.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day
timeFrame: up to 12 month
Secondary outcomes:
measure: AUC of efti given on the same day as paclitaxel
timeFrame: up to 12 month
measure: Cmax of efti given on the same day as paclitaxel
timeFrame: up to 12 month
measure: Tmax of efti given on the same day as paclitaxel
timeFrame: up to 12 month
measure: Peripheral IFN-gamma concentration in the blood
timeFrame: up to 12 month
measure: Peripheral IP-10 concentration in the blood
timeFrame: up to 12 month
measure: Overall response rate of efti in combination with weekly paclitaxel both given the same day
timeFrame: up to 12 month
measure: Median progression free survival of efti in combination with weekly paclitaxel both given the same day
timeFrame: up to 20 month
measure: Median overall survival of efti in combination with weekly paclitaxel both given the same day
timeFrame: up to 20 month
measure: To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day
timeFrame: up to 12 month
Other outcomes:
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