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 participants with non-surgically removable locally advanced or metastatic triple-negative breast cancer. The primary objective of this study for the safety run-in cohorts of the study is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC). This study in the Phase 2 Cohort 1 also compares the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone, as determined by progression-free survival (PFS) by investigator assessment. This study in the Phase 2 Cohort 2 also evaluates the efficacy of magrolimab in combination with sacituzumab govitecan as determined by confirmed objective response rate (ORR) by investigator assessment.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Triple-Negative Breast Cancer
Gender
N/A
Date
December 2021 - October 2024
Study Type
Interventional
Study Phase
Phase 2
Product
Magrolimab, Nab-Paclitaxel, Paclitaxel, Sacituzumab Govitecan-hziy
Eligibility information
Inclusion criteria
- Adequate performance status, hematologic, renal and liver function.
- Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
- Cohort 1: Individuals with previously untreated with systemic therapy for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) that are considered programmed cell death ligand 1 (PD-L1) negative (as determined by an approved test according to local regulations).
- Cohort 2: Individuals with unresectable, locally advanced or metastatic breast cancer with a diagnosis of TNBC who have received at least 1 and no more than 2 prior lines of systemic 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 criteria
- Positive serum pregnancy test or breastfeeding female.
- Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (who have been off steroids, radiation and/or surgery and/or other CNS-directed therapy for at least 4 weeks) are allowed.
- Red blood cell (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 cluster of differentiation 47 (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 adverse events (AEs) due to a previously administered agent.
- Note: Individuals with any grade of neuropathy, alopecia, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement 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.
Locations
Locations (45)
Providence Medical Foundation
Fullerton, California, United States, 92835
University of California San Francisco
San Francisco, California, United States, 94115
Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Providence Medical Foundation
Santa Rosa, California, United States, 95403
University Cancer & Blood Center,LLC
Athens, Georgia, United States, 30607
Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Southeastern Regional Medical Center, LLC
Newnan, Georgia, United States, 30265
Orchard Healthcare Research Inc
Skokie, Illinois, United States, 60077
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Allina Health Cancer Institute
Minneapolis, Minnesota, United States, 55407
NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Cairns and Hinterland Hospital and Health Service
Cairns, Queensland, Australia, 4870
University of the Sunshine Coast
Sippy Downs, Queensland, Australia, 4556
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Barwon Health- University Hospital Geelong
Geelong, Victoria, Australia, '03220
Ballarat Oncology & Haematology Services
Wendouree, Victoria, Australia, 3355
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Kaohsiung Medical University Chung-Ho Memorial Hospital
Sanmin District, Taiwan, 80778
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE1 5WW
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial