Clinical Trials /

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

NCT04252768

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Eftilagimod AlphaIMP321; eftiEftilagimod alpha + Paclitaxel
PaclitaxelEftilagimod 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

NameTypeDescriptionInterventions
Eftilagimod alpha + PaclitaxelExperimentalThe 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.

Last Updated

January 31, 2020