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Can an immune booster help chemotherapy fight metastatic breast cancer?

NCT ID NCT05747794

Disease control Sponsor: Immutep S.A.S. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether adding an experimental immunotherapy called eftilagimod alpha to standard chemotherapy (paclitaxel) can help people with HER2-negative metastatic breast cancer live longer. The study first finds the best dose of eftilagimod alpha, then compares the combination against chemotherapy alone. Participants receive the treatment in two phases: chemo-immunotherapy followed by immunotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental immunotherapy called eftilagimod alpha combined with the chemotherapy paclitaxel
What this could lead to
If it works, this could offer a new treatment option that extends survival for people with metastatic breast cancer.
What could go wrong
This is an early-to-mid-stage trial, so the combination may not prove more effective than chemotherapy alone and could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

72 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast carcinoma

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, Georgia

  • ARENSIA Exploratory Medicine Phase I Unit

    Chisinau, 2025, Moldova

  • AZ Sint-Jan Brugge Oostende av

    Bruges, Belgium

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29723, United States

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800, Belgium

  • Clinique Saint-Pierre- Ottignies

    Ottignies-Louvain-la-Neuve, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Grand Hopital de Charleroi - Hopital Notre Dame

    Charleroi, 6000, Belgium

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario de Jaén

    Jaén, 23007, Spain

  • Institut Català d'Oncologia

    Badalona, 08916, Spain

  • Oncology Consultants

    Houston, Texas, 77024, United States

  • Parc Taulí Hospital Universitari

    Barcelona, 08208, Spain

  • START Madrid - FJD, Hospital Fundación Jiménez Diaz

    Madrid, 28040, Spain

  • The George Washington University Cancer Center

    Washington D.C., District of Columbia, 20037, United States

  • The Oncology Institute

    Whittier, California, 90602, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Unidad Ensayos Clínicos Oncología Fundació IRB Lleida

    Lleida, 25196, Spain

  • Universitair Ziekenhuizen Antwerpen

    Edegem, 2650, Belgium

  • VHIO - Hospital Vall d'Hebron

    Barcelona, 08035, Spain

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