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RecruitingLast updated: 23 May 2024

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

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 patients with triple negative breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

Trial Acronym

ELEVATE TNBC

More information

Trial Identifiers

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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

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.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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