Study on Eftilagimod Alpha or Placebo with Paclitaxel Chemotherapy for Metastatic Breast Cancer Patients

Sponsor: Immutep S.A.S.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05747794

Provider View

This clinical trial is testing whether adding the drug eftilagimod alpha to standard paclitaxel chemotherapy can improve treatment outcomes for patients with metastatic breast cancer. The study will compare the safety and effectiveness of this combination against chemotherapy alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining eftilagimod alpha (efti) with the chemotherapy drug paclitaxel can help patients with metastatic breast cancer live longer compared to using paclitaxel alone. The study will first determine the best dose of efti to use with paclitaxel. Then, it will compare the effects of this combination to paclitaxel with a placebo. Participants will first receive both efti and paclitaxel or a placebo with paclitaxel, followed by treatment with efti alone.

Description

The AIPAC-003 trial is divided into two parts. The first part (Phase 2) is open-label, meaning both doctors and participants know what treatment is being given. It aims to find the safest and most effective dose of eftilagimod alpha (efti) when combined with paclitaxel chemotherapy. Two different doses of efti (30 mg and 90 mg) will be tested to see which is better tolerated and more effective. This part will include 29 participants in each group.

The second part (Phase 3) is double-blinded and placebo-controlled, meaning neither the participants nor the doctors know who is receiving efti or a placebo. This part will involve about 771 participants, who will be randomly assigned to receive either paclitaxel with the optimal dose of efti or paclitaxel with a placebo. The goal is to see if the combination of efti and paclitaxel helps patients live longer than paclitaxel alone.

The trial will take place over approximately 24 months for the first part and 60 months for the second part. It will be conducted at multiple sites across North America, Europe, Latin America, and the Asia Pacific region.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic breast cancer that is hormone receptor positive (HR+) or negative (HR-) and HER2-negative, confirmed by a biopsy.
  • For HR+ cancer, must have progressed after at least one line of hormone therapy and need chemotherapy.
  • For HR- cancer (triple-negative), must need paclitaxel chemotherapy without PD-1/PD-L1 therapy as the first treatment for metastatic disease.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have an expected survival of more than three months.

Exclusion Criteria

  • Have received chemotherapy for metastatic breast cancer before.
  • For HR+ cancer, have received less than one line of hormone therapy in the metastatic setting.
  • For HR+ cancer, not be resistant to hormone therapy and still be a candidate for it.
  • For triple-negative cancer, be a candidate for PD-1/PD-L1 therapy with chemotherapy.
  • Have a disease-free interval of less than twelve months since the last dose of adjuvant chemotherapy.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.