Key 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.