Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies. Safety Run-in Cohort 1 and Phase 2 Cohorts 1
• Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
• Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
• HNSCC per protocol specified inclusion criteria regardless of PD-L1 status. Safety Run-in Cohort 2 and Phase 2 Cohort 3
• Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting. Key

Exclusion Criteria

• Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active).
• History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
• Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC. Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
• Prior treatment with any of the following:
• Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors.
• Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors. Safety Run-in Cohort 2 and Phase 2 Cohort 3
• Prior treatment with a taxane. Note: Other protocol defined Inclusion/Exclusion criteria may apply.