Hengtai Jiukang (Tianjin) Pharmaceutical Technology Co., Ltd.

Primary objective To evaluate the tolerability and safety of nifurtimox in adult patients with high-grade glioma, medulloblastoma, brain metastasis (including but not limited to brain metastasis of lung cancer, brain metastasis of breast cancer, brain metastasis of melanoma, etc.) who have relapsed or progressed after standard treatment or have no standard treatment, and to determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D). Secondary objectives 1) To evaluate the preliminary pharmacokinetic characteristics of nifurtimox in adult patients with central nervous system tumors; 2) To evaluate the preliminary efficacy of nifurtimox in adult patients with central nervous system tumors. Exploratory objectives To explore the dosing regimen of nifurtimox in adult patients with central nervous system tumors.

Primary objective To evaluate the safety of nifurtimox alone and in combination with cyclophosphamide and topotecan in the treatment of pediatric patients with relapsed or refractory neuroblastoma, and to determine the maximum tolerated dose and the recommended dose for phase II. Secondary objectives 1) To evaluate the preliminary pharmacokinetic characteristics of nifurtimox alone and in combination with other drugs; 2) To evaluate the remission rate of nifurtimox combined with other drugs in the treatment of pediatric patients with relapsed or refractory neuroblastoma. Exploratory objective To explore the optimal dosing regimen of nifurtimox combined with other drugs.