NCT04958785

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Magrolimab	Administered intravenously
DRUG	Nab-Paclitaxel	Administered intravenously
DRUG	Paclitaxel	Administered intravenously
DRUG	Sacituzumab Govitecan-hziy	Administered intravenously

Timeline

• Start date: 2021-12-14
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2021-07-12
• Last updated: 2025-11-04
• Results posted: 2025-10-03

Locations

45 sites across 6 countries: United States, Australia, Hong Kong, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study