A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Recurrent/Metastatic Head and Neck Cancers

HE071-CSP-016

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

2021-07-01

2023-10-23

2023-10-23

Completed

Early phase I

45

Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. . Age ≥18, female or male; 3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) 4. Fail to respond to or progressed on at least one line of the standard therapy; 5. At least one measurable lesion according to RECIST v1.1; 6. ECOG performance status of 0 to 1; 7. AEs from the previous treatment have resolved to ≤ Grade 1 based on Exclusion Criteria: 1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug; 2. Untreated or symptomatic central nervous system (CNS) metastases; 3. History of allotransplantation; 4. Life expectancy \< 3 months 5. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection; 6. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration; 7. Use of other anticancer treatment within 4 weeks prior to the first dose administration; 8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration; 9. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period; 10. Thrombosis or thromboembolism within 6 months prior to screening; 11. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ; 12. Impaired cardiac function or serious cardiac disease 13. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2 14. Pregnant or lactating female; 15. Serious and/or uncontrolled systemic diseases; 16. Not suitable for this study as decided by the investigator due to other reasons.

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2024-03-07