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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer

Intervention / Treatment
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* Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoxantrone Hydrochloride Liposome Injection<br>Subjects with Rrecurrent/metastatic Head and Neck Cancers will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles | Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)<br>* All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events (AEs),,graded according to the NCI CTCAE version 5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | from the initiation of the first dose to 28 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (best total response) (BOR) | To investigate the preliminary antitumor efficacy | From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment | 
| duration of response (DoR) | To investigate the preliminary antitumor efficacy | From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years | 
| progression-free survival (PFS) | To investigate the preliminary antitumor efficacy | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years | 
| overall survival (OS) | To investigate the preliminary antitumor efficacy | from date of enrollment until date of first death from any cause, assessed up to 2 years |