A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor

• Status: Active, not recruiting
• Trial end date: 2024-04-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced solid tumor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Mitoxantrone

Criteria

Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent;

2. Age ≥18, without gender limitation;

3. Histologically and/or cytologically confirmed diagnosis of unresectable local or metastasizing advanced solid tumor;

4. Fail to respond to standard therapy or lack of effective treatment, including no standard therapy, intolerance of standard therapy, etc.;

5. At least one measurable lesion according to RECIST v1.1;

6. ECOG performance status of 0 or 1;

7. AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);

8. Adequate organ function;

9. Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrollment;

10. Fully comply with the protocol.

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. CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;

4. History of allotransplantation;

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. Life expectancy<12 weeks;

15. Pregnant or lactating female;

16. Serious and/or uncontrolled systemic diseases;

17. Not suitable for this study as decided by the investigator due to other reasons.