Neutron Science (Chongqing) Research Institute Co., Ltd.

Primary objectives: 1) Evaluate the safety of injectable boro[10B]phalan in the treatment of patients with recurrent or unresectable head and neck malignancies; 2) Evaluate the safety of the boron neutron capture therapy system in the treatment of patients with recurrent or unresectable head and neck malignancies; 3) Determine the recommended Phase II dose (RP2D) for boron neutron capture therapy (BNCT). Secondary objectives: 1) Evaluate the efficacy of injectable boro[10B]phalan and the boron neutron capture therapy system for BNCT in patients with recurrent or unresectable head and neck malignancies; 2) Evaluate the device performance of the boron neutron capture therapy system during BNCT (device stability, device failure, and overall performance evaluation); 3) Evaluate the pharmacokinetic (PK) characteristics of injectable boro[10B]phalan in patients with recurrent or unresectable head and neck malignancies.