Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
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.
Timeline
- Start
- 2021-12-14
- Primary completion
- 2024-10-08
- Completion
- 2024-10-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magrolimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Subject | Magrolimab | Monoclonal antibody | 60 mg/kg | Intravenous |
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |