Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
GS-US-586-6144 (primary)
NCI-2022-00926
2021-001074-27
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.
Objectives
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).
The primary objective of this study for Phase 2 Cohort 1 is to compare 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.
The primary objective of this study for Phase 2 Cohort 2 is to evaluate the efficacy of
magrolimab in combination with sacituzumab govitecan as determined by confirmed objective
response rate (ORR) by investigator assessment.
Eligibility
- Adequate performance status, hematologic, renal and liver function.
- Measurable disease per RECIST v1.1
- Cohort 1: Individuals with previously untreated with systemic therapy for 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 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.
Treatment Sites in Georgia
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