Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Where in United States
- Athens · University Cancer & Blood Center, LLCUnknown status
- Atlanta · Winship Cancer Institute, Emory UniversityUnknown status
- Charleston · Charleston OncologyUnknown status
- East Brunswick · Astera Cancer CareUnknown status
- Fresno · Women's Cancer CareUnknown status
- Fullerton · Providence Medical FoundationUnknown status
- Jacksonville · Mayo ClinicUnknown status
- Minneapolis · Allina Health Cancer InstituteUnknown status
- New Orleans · Ochsner Clinic FoundationUnknown status
- New York · NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer CenterUnknown status
- Newnan · Southeastern Regional Medical Center, LLCUnknown status
- Phoenix · Mayo ClinicUnknown status
- Rochester · Mayo ClinicUnknown status
- Salt Lake City · Huntsman Cancer Institute/University of UtahUnknown status
- San Francisco · University of California San FranciscoUnknown status
- Santa Monica · Saint John's Cancer InstituteUnknown status
- Santa Rosa · Providence Medical FoundationUnknown status
- Skokie · Orchard Healthcare Research Inc.Unknown status
- Stony Brook · Stony Brook UniversityUnknown status
Also in 5 other countries, 26 sites
Australia 10, South Korea 5, Taiwan 5, Hong Kong 3, United Kingdom 3.
The registry text, word for word
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
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.
Inclusion: 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: Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents; 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; 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; History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months; Known inherited or acquired bleeding disorders; Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy; Positive serum pregnancy test or breastfeeding female; 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.