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NCT05747794 · ClinicalTrials.gov record · last posted 2026-07-30

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

Study acronym: AIPAC-003
StatusTerminated
PhasePhase 2/3
Started2023-05-22
View on ClinicalTrials.gov ↗
Why the trial stopped
Sponsor Decision
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-07-31
Trial terminated
2026-07-31
Trial terminated: Sponsor Decision
2026-07-31
Primary endpoint(s) modified
WasDetermination of Overall survival (OS), Determination of the Optimal Biological Dose (OBD), Duration of adverse events (AEs), Frequency of adverse events (AEs), Occurrence of clinically relevant abnormalities in 12-lead ECGs, Occurrence of clinically relevant abnormalities in physical examinations, Occurrence of clinically relevant abnormalities in safety laboratory assessments, Occurrence of clinically relevant abnormalities in vital signs, Occurrence of dose-limiting toxicities (DLTs), Severity of adverse events (AEs)
NowDetermination of Overall survival (OS), Determination of the Optimal Biological Dose (OBD), Duration of adverse events (AEs), Frequency of adverse events (AEs), Occurrence of dose-limiting toxicities (DLTs), Severity of adverse events (AEs)
2026-07-31
Enrollment reduced: 849 → 72 participants
2026-07-31
Primary completion moved earlier: 2026-10-31 → 2026-04-30
2026-07-31
Completion moved earlier: 2027-07-31 → 2026-06-30
Trial Details
NCT Number NCT05747794
Lead Sponsor Immutep S.A.S.
Conditions Breast Carcinoma
Enrollment 72 participants
Start Date 2023-05-22
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-30