癌研連線CancerLink
Terminated NCT04854499

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

Head & Neck CancerPhase 2Stage IIIStage IVPD-L1

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in participants with head and neck squamous cell carcinoma (HNSCC).

Conditions: Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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.
  • 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.

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.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.