JenKem Technology Co., Ltd.

Primary purpose: To evaluate the effectiveness of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases. Secondary purpose: To evaluate the safety of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases; To evaluate the population pharmacokinetic characteristics of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases.

Primary objective: To evaluate the efficacy of JK1201I compared with topotecan hydrochloride injection in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment. Secondary objectives: 1) To evaluate the safety of JK1201I compared with topotecan hydrochloride injection in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment; 2) To evaluate the population pharmacokinetic properties of JK1201I in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment.

Main purpose Evaluate the safety and tolerability of polyethylene glycol irinotecan for injection combined with temozolomide in subjects with glioma Secondary purpose 1) Preliminary observation of the effectiveness of polyethylene glycol irinotecan for injection combined with temozolomide in subjects with glioma, and provide a basis for the recommended dose and administration method for subsequent clinical trials 2) Investigate the pharmacokinetic characteristics of polyethylene glycol irinotecan for injection combined with temozolomide in subjects with glioma, and obtain the pharmacokinetic parameters after combined administration