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

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT04958785
Trial Phases:	Phase II	Protocol IDs:	GS-US-586-6144 (primary) NCI-2022-00926 2021-001074-27
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Gilead
NCI Full Details:	http://clinicaltrials.gov/show/NCT04958785

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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