This is a multicenter, open-label, phase I dose-escalation and dose-expansion study aimed to evaluate the tolerability, safety, pharmacokinetics and efficacy of mitoxantrone hydrochloride liposome injection combination therapy. This study consists of two phases: dose-escalation phase and dose expansion phase.~The dose-escalation phase will be conducted to determine the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome injection combination therapy in patients with advanced solid tumors based on a Rolling-6 design. Patients enrolled in this phase will be allocated to two arms A and B. The patients of A arm will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The patients of B arm will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period.~After DLT observation, one dose cohort will be selected for dose-expansion to further explore the safety and efficacy of study drug according to the dose-escalation results. In the dose-expansion phase, patients will receive mitoxantrone hydrochloride liposome injection combination therapy every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 6 cycles).
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese patients with advanced solid tumors.