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STATUS Recruiting

Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (ELEVATE TNBC)

LAST UPDATED

November 24, 2023

Clinicaltrials.gov ID

NCT04958785

EudraCT ID

2021-001074-27

OVERVIEW

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer (ELEVATE TNBC)

PROTOCOL SUMMARY

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with nab-paclitaxel or paclitaxel (cohort 1) or with sacituzumab govitecan-hziy (cohort 2) in patients with non-surgically removable locally advanced or metastatic triple-negative breast cancer.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Triple-Negative Breast Cancer

Gender

N/A

Date

December 2021 - August 2024

Study Type

Interventional

Study Phase

Phase 2

Product

Magrolimab, Nab-Paclitaxel, Paclitaxel, Sacituzumab Govitecan-hziy

Eligibility Information

Inclusion

Inclusion Criteria

  • 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.
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Exclusion

Exclusion Criteria

  • 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.
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Locations

Locations (47)
Recruiting

Mayo Clinic

Phoenix, Arizona, United States, 85054

Recruitment Complete

Women's Cancer Care

Fresno, California, United States, 93710

Recruiting

Providence Medical Foundation

Fullerton, California, United States, 92835

Recruiting

University of California San Francisco

San Francisco, California, United States, 94115

Recruiting

Saint John's Cancer Institute

Santa Monica, California, United States, 90404

Recruiting

Providence Medical Foundation

Santa Rosa, California, United States, 95403

Recruiting

Mayo Clinic

Jacksonville, Florida, United States, 32224

Withdrawn

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, United States, 32308

Recruiting

University Cancer & Blood Center,LLC

Athens, Georgia, United States, 30607

Recruiting

Winship Cancer Institute Emory University

Atlanta, Georgia, United States, 30322

Recruiting

Southeastern Regional Medical Center, LLC

Newnan, Georgia, United States, 30265

Recruiting

Orchard Healthcare Research Inc

Skokie, Illinois, United States, 60077

Recruiting

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Recruiting

Allina Health Cancer Institute

Minneapolis, Minnesota, United States, 55407

Recruiting

Mayo Clinic

Rochester, Minnesota, United States, 55905

Recruiting

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

Recruiting

NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center

New York, New York, United States, 10016

Recruiting

Stony Brook University

Stony Brook, New York, United States, 11794

Recruitment Complete

Charleston Oncology

Charleston, South Carolina, United States, 29414

Recruiting

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

Recruiting

Cairns and Hinterland Hospital and Health Service

Cairns, Queensland, Australia, 4870

Recruiting

University of the Sunshine Coast

Sippy Downs, Queensland, Australia, 4556

Recruiting

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Recruiting

Cancer Research SA

Adelaide, South Australia, Australia, 5000

Recruiting

Flinders Medical Centre

Bedford Park, South Australia, Australia, 5042

Recruiting

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Recruiting

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Recruiting

Peninsula Health

Frankston, Victoria, Australia, 3199

Recruiting

Barwon Health- University Hospital Geelong

Geelong, Victoria, Australia, '03220

Recruitment Complete

Ballarat Oncology & Haematology Services

Wendouree, Victoria, Australia, 3355

Withdrawn

Hong Kong United Oncology Centre

Hong Kong, Hong Kong

Recruiting

Queen Mary Hospital

Hong Kong, Hong Kong

Recruiting

Princess Margaret Hospital

Kowloon, Hong Kong

Recruiting

Prince of Wales Hospital

New Territories, Hong Kong

Recruiting

Samsung Medical Center

Gangnam-Gu, Korea, Republic of, 06351

Recruiting

National Cancer Center

Goyang-si, Korea, Republic of, 10408

Recruiting

Seoul National University Hospital

Jongrogu, Korea, Republic of, 110-744

Recruiting

Severance Hospital Yonsei University Health System

Seoul, Korea, Republic of, 03722

Recruiting

Asan Medical Center

Seoul, Korea, Republic of, 5505

Recruiting

Taipei Veterans General Hospital

Beitou District, Taiwan, 11257

Recruiting

Changhua Christian Hospital

Changhua City, Taiwan, 50006

Recruiting

Chang Gung Memorial Hospital, Linkou

Guishan District, Taiwan, 131

Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Sanmin District, Taiwan, 80778

Recruiting

National Taiwan University Hospital

Tapiei, Taiwan

Recruiting

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom, LE1 5WW

Recruiting

University College London

London, United Kingdom, WC1E 6BT

Recruiting

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX