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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05747794

Run by

Immutep S.A.S.

People needed

72

Starts

2023-05-22

Expected to finish

2026-06-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Oncology Institute — Whittier, California, United States
• The George Washington University Cancer Center — Washington D.C., District of Columbia, United States
• Carolina Blood and Cancer Care Associates — Rock Hill, South Carolina, United States
• Oncology Consultants — Houston, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• AZ Sint-Jan Brugge Oostende av — Bruges, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Grand Hopital de Charleroi - Hopital Notre Dame — Charleroi, Belgium
• Universitair Ziekenhuizen Antwerpen — Edegem, Belgium
• Centre Hospitalier de l'Ardenne — Libramont, Belgium
• Clinique Saint-Pierre- Ottignies — Ottignies-Louvain-la-Neuve, Belgium
• ARENSIA Exploratory Medicine LLC — Tbilisi, Georgia
• ARENSIA Exploratory Medicine Phase I Unit — Chisinau, Moldova
• Institut Català d'Oncologia — Badalona, Spain
• VHIO - Hospital Vall d'Hebron — Barcelona, Spain
• Hospital Clinic de Barcelona — Barcelona, Spain
• Parc Taulí Hospital Universitari — Barcelona, Spain
• Hospital Universitario Reina Sofia — Córdoba, Spain
• Hospital Universitario de Jaén — Jaén, Spain
• Unidad Ensayos Clínicos Oncología Fundació IRB Lleida — Lleida, Spain
• START Madrid - FJD, Hospital Fundación Jiménez Diaz — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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