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

Study Identifier:
IMP321-P016 (AIPAC-003)
CT.gov Identifier:
NCT05747794
EudraCT Identifier:
2022-003323-17
EU Trial (CTIS) Number:
2024-511023-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate IMP321 in patients with metastatic breast cancer.

To determine the optimal biological dose consistent with the FDA’s Project Optimus initiative.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II/III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
    • Read More
  • Drug: Drug: Paclitaxel
  • Drug: Patients have been randomised 1: 1 to receive either 30mg or 90mg dosing of eftilagimod alpha (efti”) in combination with paclitaxel.
  • Drug: Experimental: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
  • Drug: Experimental: Phase 3: eftilagimod alpha + paclitaxel
  • Drug: Placebo Comparator: Phase 3: placebo + paclitaxel
  • Drug: Other: placebo
  • Drug: ASCO 2023:
  • Drug: Phase II: patients who will receive 30mg efti or 90mg efti
  • Drug: ASCO 2024
  • Drug: ...Pts will receive paclitaxel (80 mg/m2 I.V. on D1, 8 and 15 in a 4-week cycle), followed by efti or placebo (DOL: 30 or 90 mg efti; Phase 3: OBD of efti or placebo) S.C. on D1 and 15 in a 4-week cycle for up to 12 months. Imaging is done every 8 weeks and assessed by the investigator. in the DOL blood samples are taken from 0 to 96 hours in cycle 1 and 4 to determine PK / PD profiles. PK / PD parameters are assessed by a central lab.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Pts with either a) HR+ and HER2-neg/low and endocrine therapy-resistant MBC or b) TNBC not eligible for anti-PD-1-based therapy. Pts must have measurable disease, ECOG PS 0-1 and no prior chemotherapy for metastatic disease.
    • 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
    Exclusion criteria
    • Pts if HR+ who are not considered endocrine resistant and/or have received < 1 line of therapy in the metastatic setting. Pts who are considered TNBC and are eligible for anti-PD-(L)1 containing therapy.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Breast Cancers