Trial Title:
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy
NCT ID:
NCT05747794
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This trial consists of an open-label dose optimization lead-in component (phase 2)
followed by a double-blinded, randomized, placebo-controlled phase 3 component.
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
eftilagimod alpha
Description:
APC activator, MHC II agonist
Arm group label:
Phase 3: eftilagimod alpha + paclitaxel
Arm group label:
open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
Arm group label:
open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
Other name:
IMP321
Other name:
efti
Other name:
LAG-3Ig
Other name:
eftilagimod alfa
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
paclitaxel will be given as standard of care (chemotherapy)
Arm group label:
Phase 3: eftilagimod alpha + paclitaxel
Arm group label:
Phase 3: placebo + paclitaxel
Arm group label:
open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
Arm group label:
open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
Intervention type:
Other
Intervention name:
placebo
Description:
placebo matching eftilagimod alpha
Arm group label:
Phase 3: placebo + paclitaxel
Other name:
placebo matching eftilagimod alpha
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Oncology Institute
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omkar Marathe, MD
Facility:
Name:
The George Washington University Cancer Center
Address:
City:
Washington
Zip:
20037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pavani Chalasani, MD
Facility:
Name:
Carolina Blood and Cancer Care Associates
Address:
City:
Rock Hill
Zip:
29723
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sashi Naidu, MD
Facility:
Name:
Oncology Consultants
Address:
City:
Houston
Zip:
77024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julio Peguero, MD
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nuhad Ibrahim, MD
Facility:
Name:
AZ Sint-Jan Brugge Oostende av
Address:
City:
Brugge
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Eveline De Cuypere, MD
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussel
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Francois Duhoux, MD
Facility:
Name:
Grand Hopital de Charleroi - Hopital Notre Dame
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Jean-Luc Canon, MD
Facility:
Name:
Universitair Ziekenhuizen Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Konstantinos Papadimitriou, MD
Facility:
Name:
Centre Hospitalier de l'Ardenne
Address:
City:
Libramont
Zip:
6800
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Frederic Forget, MD
Facility:
Name:
Clinique Saint-Pierre- Ottignies
Address:
City:
Ottignies-Louvain-la-Neuve
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Renard Poncin, MD
Facility:
Name:
ARENSIA Exploratory Medicine LLC
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Marina Maglakelidze, MD
Facility:
Name:
ARENSIA Exploratory Medicine Phase I Unit
Address:
City:
Chisinau
Zip:
2025
Country:
Moldova, Republic of
Status:
Recruiting
Contact:
Last name:
Lurie Bulat, MD
Facility:
Name:
Institut Català d'Oncologia
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Anna Pous, MD
Facility:
Name:
VHIO - Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Mafalda Oliveira, MD
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Elia Seguí, MD
Facility:
Name:
Parc Taulí Hospital Universitari
Address:
City:
Barcelona
Zip:
08208
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Luis Férnández-Morales, MD
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan De la Haba, MD
Facility:
Name:
Hospital Universitario de Jaén
Address:
City:
Jaén
Zip:
23007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pedro Sánchez Rovira, MD
Facility:
Name:
Unidad Ensayos Clínicos Oncología Fundació IRB Lleida
Address:
City:
Lleida
Zip:
25196
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Serafin Morales Murillo, MD
Facility:
Name:
START Madrid - FJD, Hospital Fundación Jiménez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Bernard Doger, MD
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pilar Zamora Auñón, MD
Start date:
May 22, 2023
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Immutep S.A.S.
Agency class:
Industry
Source:
Immutep S.A.S.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747794
