Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy (AIPAC-003)
AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
The main questions it aims to answer are:
- What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
- Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone?
In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled).
The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The AIPAC-003 trial consists of an open-label dose optimization lead-in component followed by a double-blinded, randomized, placebo-controlled phase 3 component.
The main objectives of the dose optimization lead-in (phase 2) are to evaluate and compare the safety and tolerability of 2 different dose levels of efti (30 mg and 90 mg) combined with paclitaxel, and to define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for the phase 3 part of the trial. Recruitment to the dose-optimization lead-in will be considered complete when 29 participants per cohort are randomized and considered evaluable for OBD analysis.
The main objective of the phase 3 is to demonstrate that overall survival (OS) is superior in participants treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo. Approximately 771 participants will be randomized 2:1 to Arm A (active arm): paclitaxel + efti at OBD and Arm B (control arm): paclitaxel + placebo. The exact patient population will be defined after determination of the OBD.
The duration of the trial will be approximately 24 months for the dose optimization lead-in component and 60 months for the phase 3 component. The phase 3 will start prior to the completion of the phase 2 (once the OBD has been defined).
It is planned to conduct the trial at up to 20 sites in up to 4 countries across North America and Europe for the lead-in and at up to 150 sites in up to 25 countries across North America, Europe, Latin America and the Asian Pacific region for the phase 3.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Bruges, Belgium
- AZ Sint-Jan Brugge Oostende av
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Charleroi, Belgium, 6000
- Grand Hopital de Charleroi - Hopital Notre Dame
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Edegem, Belgium, 2650
- Universitair Ziekenhuizen Antwerpen
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Libramont, Belgium, 6800
- Centre Hospitalier de l'Ardenne
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Ottignies-Louvain-la-Neuve, Belgium
- Clinique Saint-Pierre- Ottignies
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Tbilisi, Georgia
- Arensia Exploratory Medicine Llc
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Chisinau, Moldova, 2025
- ARENSIA Exploratory Medicine Phase I Unit
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Badalona, Spain, 08916
- Institut Catala d'Oncologia
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spain, 08035
- VHIO - Hospital Vall d'Hebron
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Barcelona, Spain, 08208
- Parc Taulí Hospital Universitari
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Córdoba, Spain, 14004
- Hospital Universitario Reina Sofia
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Jaén, Spain, 23007
- Hospital Universitario de Jaén
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Lleida, Spain, 25196
- Unidad Ensayos Clínicos Oncología Fundació IRB Lleida
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28040
- START Madrid - FJD, Hospital Fundación Jiménez Diaz
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California
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Whittier, California, United States, 90602
- The Oncology Institute
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District of Columbia
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Washington D.C., District of Columbia, United States, 20037
- The George Washington University Cancer Center
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South Carolina
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Rock Hill, South Carolina, United States, 29723
- Carolina Blood and Cancer Care Associates
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Texas
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center
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Houston, Texas, United States, 77024
- Oncology Consultants
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
- Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
- Participants with HR- MBC (i.e. triple-negative breast cancer [TNBC]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
- ECOG performance status 0-1
- Expected survival longer than three months
Exclusion Criteria:
- Prior chemotherapy for metastatic breast adenocarcinoma
- Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting
- Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
- TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
eftilagimod alpha 30mg s.c.
+ 80mg/m^2 paclitaxel i.v.
(same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase.
The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance.
The IO-phase is planned to follow the chemo-IO phase.
A maximum of 13 cycles (approx.
12 months) of treatment is planned.
|
APC activator, MHC II agonist
Other Names:
paclitaxel will be given as standard of care (chemotherapy)
|
|
Experimental: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
eftilagimod alpha 90mg s.c.
+ 80mg/m^2 paclitaxel i.v.
(same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase.
The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance.
The IO-phase is planned to follow the chemo-IO phase.
A maximum of 13 cycles (approx.
12 months) of treatment is planned.
|
APC activator, MHC II agonist
Other Names:
paclitaxel will be given as standard of care (chemotherapy)
|
|
Experimental: Phase 3: eftilagimod alpha + paclitaxel
eftilagimod alpha s.c.
(OBD) + 80mg/m^2 paclitaxel i.v.
(same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase.
The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance.
The IO-phase is planned to follow the chemo-IO phase.
A maximum of 13 cycles (approx.
12 months) of treatment is planned.
|
APC activator, MHC II agonist
Other Names:
paclitaxel will be given as standard of care (chemotherapy)
|
|
Placebo Comparator: Phase 3: placebo + paclitaxel
placebo s.c.
+ 80mg/m^2 paclitaxel i.v.
(same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase.
The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance.
The IO-phase is planned to follow the chemo-IO phase.
A maximum of 13 cycles (approx.
12 months) of treatment is planned.
|
paclitaxel will be given as standard of care (chemotherapy)
placebo matching eftilagimod alpha
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of the Optimal Biological Dose (OBD)
Time Frame: Up to 15 months
|
Up to 15 months
|
|
|
Frequency of adverse events (AEs)
Time Frame: Up to 15 months
|
Up to 15 months
|
|
|
Severity of adverse events (AEs)
Time Frame: Up to 15 months
|
Up to 15 months
|
|
|
Duration of adverse events (AEs)
Time Frame: Up to 15 months
|
Up to 15 months
|
|
|
Occurrence of dose-limiting toxicities (DLTs)
Time Frame: Up to 15 months
|
Up to 15 months
|
|
|
Determination of Overall survival (OS)
Time Frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
|
Primary endpoint for Phase 3 portion, secondary endpoint for Phase 2 lead-in portion
|
Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determination of Progression Free Survival (PFS), based on RECIST, v1.1
Time Frame: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
|
Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
|
|
Evaluation of Objective Response Rate (ORR) based on RECIST v1.1
Time Frame: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
|
Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIPAC-003
- 2022-003323-17 (EudraCT Number)
- 2024-511023-34-00 (Ctis)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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