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Study identifier: NCT05747794 Synced from ClinicalTrials.gov · August 04, 2026
● Terminated

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

Condition: Breast Carcinoma  ·  Sponsor: Immutep S.A.S.

PhasePhase 2/Phase 3
Planned participants72
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (22)

The Oncology InstituteWhittier, California, United States
The George Washington University Cancer CenterWashington D.C., District of Columbia, United States
Carolina Blood and Cancer Care AssociatesRock Hill, South Carolina, United States
Oncology ConsultantsHouston, Texas, United States
The University of Texas MD Anderson Cancer CenterHouston, Texas, United States
AZ Sint-Jan Brugge Oostende avBruges, Belgium
Cliniques Universitaires Saint-LucBrussels, Belgium
Grand Hopital de Charleroi - Hopital Notre DameCharleroi, Belgium
Universitair Ziekenhuizen AntwerpenEdegem, Belgium
Centre Hospitalier de l'ArdenneLibramont, Belgium
Clinique Saint-Pierre- OttigniesOttignies-Louvain-la-Neuve, Belgium
ARENSIA Exploratory Medicine LLCTbilisi, Georgia

+ 10 more locations — full list on the registry record.

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