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

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

Study Purpose

This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06586866
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	JenKem Technology Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Triple Negative Breast Cancer (TNBC), Brain Metastasases

Additional Details

This is a multicenter, single-arm, phase 2 study to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases. Patients will receive JK-1201I until disease progression. The primary objective of this study is to assess whether treatment with JK-1201I prolongs progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM in triple negative breast cancer patients with brain metastases. The secondary objectives of the study are to further evaluate the efficacy, safety and pharmacokinetics of JK-1201I.

Arms & Interventions

Arms

Experimental: JK-1201I

Participants will receive JK-1201I as an intravenous (IV) infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle until a treatment discontinuation criterion is met as specified in the protocol.