A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers

This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with recurrent/metastatic head and neck cancers. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawa by investigator or patient decision (a maximum of 8 cycles). Delays in drug administration is allowed from the cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after the cycle 2 is permitted, and the minimum dose is 12mg/m2.

Inclusion criteria

• Subjects fully understand and voluntarily participate in this study and sign informed consent;
• . Age ≥18, female or male;
• Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
• Fail to respond to or progressed on at least one line of the standard therapy;
• At least one measurable lesion according to RECIST v1.1;
• ECOG performance status of 0 to 1;
• AEs from the previous treatment have resolved to ≤ Grade 1 based on

Exclusion criteria

• History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
• Untreated or symptomatic central nervous system (CNS) metastases;
• History of allotransplantation;
• Life expectancy < 3 months
• Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
• Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
• Use of other anticancer treatment within 4 weeks prior to the first dose administration;
• Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
• Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
• Thrombosis or thromboembolism within 6 months prior to screening;
• History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
• Impaired cardiac function or serious cardiac disease
• Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2
• Pregnant or lactating female;
• Serious and/or uncontrolled systemic diseases;
• Not suitable for this study as decided by the investigator due to other reasons.