这项临床研究的目标是了解研究药物 Magrolimab 与其他抗癌治疗联合用于头颈鳞状细胞癌(HNSCC)患者的安全性、耐受性、剂量及有效性。
适应症:Head and Neck Squamous Cell Carcinoma
入组条件
纳入标准
- 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.
排除标准
- 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。