China Boron (Xiamen) Biopharmaceutical Co., Ltd.

Phase Ia: Primary objective: To evaluate the safety and tolerability of boron neutron capture therapy (BNCT) using NBB-001 and BNCT system in patients with recurrent head and neck malignancies; to determine the recommended Phase II dose (RP2D) of NBB-001. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of NBB-001 in patients with recurrent head and neck malignancies; to evaluate the effectiveness of BNCT of NBB-001 and BNCT system in patients with recurrent head and neck malignancies; and the device performance of BNCT system during BNCT implementation. To evaluate the relationship between the tumor-to-normal tissue boron concentration ratio (TNR) indicated by 18F-BPA-PET/CT examination and the efficacy. Phase Ib: Primary objective: To evaluate the effectiveness of BNCT of NBB-001 and BNCT system in the treatment of patients with recurrent head and neck malignancies. Secondary objectives: To evaluate the safety of NBB-001 and BNCT system in the treatment of patients with recurrent head and neck malignancies using boron neutron capture therapy (BNCT); to evaluate the device performance of the BNCT system during BNCT implementation; and to evaluate the relationship between the tumor-to-normal tissue boron concentration ratio (TNR) indicated by 18F-BPA-PET/CT examination and the therapeutic effect.