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AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

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AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Eftilagimod alpha (Primary) ; Paclitaxel (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Carcinoma; HER2 negative breast cancer; Triple negative breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms AIPAC-003
  • Sponsors Immutep Limited

Most Recent Events

  • 29 Apr 2025 According to an Immutep Limited media release, company completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patient follow up, data cleaning and analysis is ongoing and an update is anticipated in CY2025.
  • 31 Jan 2025 According to an Immutep Limited media release,Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA Project Optimus initiative and prior regulatory interaction with FDA. Data cleaning and analysis is ongoing.
  • 03 Oct 2024 Status changed from recruiting to active, no longer recruiting, according to an Immutep Limited media release.

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