已終止 NCT04854499

Magrolimab 聯合治療用於頭頸鱗狀細胞癌患者的研究

頭頸癌Phase IIIII 期IV 期PD-L1

這項臨床研究的目標是了解研究藥物 Magrolimab 與其他抗癌治療聯合用於頭頸鱗狀細胞癌(HNSCC)患者的安全性、耐受性、劑量及有效性。

適應症:Head and Neck Squamous Cell Carcinoma

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。