JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases

You may be eligible if

• Inclusion
• Participants must meet all the following criteria to be eligible for randomization into the study:
• 1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• 2. Female aged ≥18 years.
• 3. Has ECOG PS of ≤1.
• 4. Life expectancy ≥ 3months.
• 5. Histological or cytological confirmation of triple-negative breast cancer (TNBC).
• 6. At least one prior chemotherapy regimen with anthracyclines and taxanes for advanced disease.
• 7. Has at least 1 measurable brain metastatic lesion according to RANO-BM.
• 8. Adequate biological function.
• 9. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.
• Exclusion
• Participants who meet any of the following criteria will be disqualified from entering the study:
• 1. Patients who have received prior anti-cancer treatment within 4 weeks.
• 2. . Patients must not have previously received JK-1201I or any other form of irinotecan, SN38.
• 3. Hypersensitivity to any ingredient of JK-1201I and Topotecan.
• 4. Current use or any use in the last two weeks of strong CYP3A-enzyme inducers / in the last two weeks of strong CYP3A-enzyme inhibitors and / or strong UGT1A inhibitors.
• 5. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
• 6. History of other malignancies within last 5 years.
• 7. History of immunodeficiency disease, or positive human immunodeficiency virus antibody.
• 8. Severe infections within 4 weeks before the first use of the study drug.
• 9. Active hepatitis B virus infection, or active hepatitis C virus infection.
• 10. Patients who received surgery within last 4 weeks before the initiation of study treatment.
• 11. Patients with brain stem, meningeal or spinal cord metastasis.
• 12. Severe symptoms by tumor aggressive important organ.
• 13. Uncontrolled hydrothorax and ascites.
• 14. Uncontrolled concomitant systemic disorder as defined in the protocol.
• 15. Serious cardiac condition or uncontrolled high blood pressure.
• 16. History of mental illness, drug abuse, alcoholism.
• 17. Pregnant or breast-feeding.
• 18. Other conditions that the investigator considers unsuitable to participate in this clinical trial.