[Translation] A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Boron Neutron Capture Therapy (BNCT) with NBB-001 and the Boron Neutron Capture Therapy System in Patients with Recurrent Head and Neck Malignancies
Ia期:主要目的:评价使用NBB-001和硼中子俘获治疗系统的硼中子俘获疗法(BNCT)在复发性头颈部恶性肿瘤患者中的安全性、耐受性;确定NBB-001的II期推荐剂量(RP2D)。次要目的:评估NBB-001在复发性头颈部恶性肿瘤患者中的药代动力学(PK)特征;评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法(BNCT)在复发性头颈部恶性肿瘤患者中的有效性;BNCT实施中硼中子俘获治疗系统的器械性能。评估18F-BPA-PET/CT检查提示的肿瘤与正常组织的硼浓度比(TNR)与疗效的关系。
Ib期:主要目的:评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法(BNCT)治疗复发性头颈部恶性肿瘤患者中的有效性。次要目的:评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法(BNCT)治疗复发性头颈部恶性肿瘤患者中的安全性;评估BNCT实施中硼中子俘获治疗系统的器械性能;评估18F-BPA-PET/CT检查提示的肿瘤与正常组织的硼浓度比(TNR)与疗效的关系。
[Translation] Phase Ia: Main purpose: To evaluate the safety and tolerability of boron neutron capture therapy (BNCT) using NBB-001 and boron neutron capture therapy system in patients with recurrent head and neck malignancies; to determine the efficacy of NBB-001 Recommended Phase II Dose (RP2D). Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of NBB-001 in patients with recurrent head and neck malignancies; to evaluate the efficacy of NBB-001 and boron neutron capture therapy (BNCT) of the Boron Neutron Capture Therapy System in patients with recurrent head and neck malignancies. effectiveness in patients with head and neck malignant tumors; device performance of the boron neutron capture therapy system in BNCT implementation. To evaluate the relationship between the boron concentration ratio (TNR) of tumor and normal tissue suggested by 18F-BPA-PET/CT examination and the efficacy.
Phase Ib: Primary purpose: To evaluate the effectiveness of boron neutron capture therapy (BNCT) with NBB-001 and the boron neutron capture therapy system in the treatment of patients with recurrent head and neck malignancies. Secondary objectives: To evaluate the safety of NBB-001 and the Boron Neutron Capture Therapy System in the treatment of patients with recurrent head and neck malignancies with boron neutron capture therapy (BNCT); to evaluate the device of the Boron Neutron Capture Therapy System in the implementation of BNCT Performance; evaluate the relationship between the boron concentration ratio (TNR) of tumors and normal tissues suggested by 18F-BPA-PET/CT examination and the efficacy.