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No longer recruiting (closed or complete)Last updated: 14 March 2025

ELEVATE TNBC: This trial is evaluating the addition of a targeted cancer drug (Magrolimab) to chemotherapy (using Nab-Paclitaxel or Paclitaxel) for the treatment of people with triple negative breast cancer that has spread to other parts of the bodyA Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Nab-Paclitaxel or Paclitaxel Versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Patients With Metastatic Triple-Negative Breast Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

ELEVATE TNBC

Clinical summary

Summary

Eligible participants will include a safety run-in cohort to establish a recommended phase two dose (RP2D) of Magrolimab. Following the safety run-in cohort, eligible participants will be randomised into one of two experimental treatment arms.

Participants in one arm will receive the RP2D of Magrolimab in combination with Nab-Paclitaxel (100mg/m^2) or Paclitaxel (90mg/m^2) on Days 1, 8 and 15 of each 28-day treatment cycle.

Participants in the other arm won't receive treatment with Magrolimab.

Conditions

This trial is treating people with triple negative breast cancer

Eligibility

Inclusion

  • Adequate performance status, hematologic, renal and liver function.
  • Measurable disease per RECIST v1.1
  • Cohort 1: Individuals with previously untreated unresectable locally advanced or metastatic TNBC that are considered PD-L1 negative (as determined by an approved test according to local regulations).
  • Cohort 2: Individuals with unresectable, locally advanced or metastatic TNBC who have received at least 1 and no more than 2 prior lines of therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC.

Exclusion

  • Positive serum pregnancy test or breastfeeding female.
  • Active CNS disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
  • RBC transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
  • Prior treatment with CD47 or signal regulatory protein alpha-targeting agents.
  • Known inherited or acquired bleeding disorders.
  • Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy.
  • Cohort 2 only:

    • Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and Individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment.
    • Individuals who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor.
    • High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1.
    • Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.

      • Note: individuals with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
      • Note: if individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Gilead Sciences

Scientific Title

A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Nab-Paclitaxel or Paclitaxel Versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Patients With Metastatic Triple-Negative Breast Cancer

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