Status:
NOT_YET_RECRUITING
JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
Lead Sponsor:
JenKem Technology Co., Ltd.
Conditions:
Triple Negative Breast Cancer (TNBC)
Brain Metastasases
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.
Detailed Description
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 recei...
Eligibility Criteria
Inclusion
- Inclusion
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Female aged ≥18 years.
- Has ECOG PS of ≤1.
- Life expectancy ≥ 3months.
- Histological or cytological confirmation of triple-negative breast cancer (TNBC).
- At least one prior chemotherapy regimen with anthracyclines and taxanes for advanced disease.
- Has at least 1 measurable brain metastatic lesion according to RANO-BM.
- Adequate biological function.
- 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:
- Patients who have received prior anti-cancer treatment within 4 weeks.
- . Patients must not have previously received JK-1201I or any other form of irinotecan, SN38.
- Hypersensitivity to any ingredient of JK-1201I and Topotecan.
- 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.
- 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.
- History of other malignancies within last 5 years.
- History of immunodeficiency disease, or positive human immunodeficiency virus antibody.
- Severe infections within 4 weeks before the first use of the study drug.
- Active hepatitis B virus infection, or active hepatitis C virus infection.
- Patients who received surgery within last 4 weeks before the initiation of study treatment.
- Patients with brain stem, meningeal or spinal cord metastasis.
- Severe symptoms by tumor aggressive important organ.
- Uncontrolled hydrothorax and ascites.
- Uncontrolled concomitant systemic disorder as defined in the protocol.
- Serious cardiac condition or uncontrolled high blood pressure.
- History of mental illness, drug abuse, alcoholism.
- Pregnant or breast-feeding.
- Other conditions that the investigator considers unsuitable to participate in this clinical trial.
Exclusion
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 26 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06586866
Start Date
September 26 2024
End Date
October 26 2026
Last Update
September 19 2024
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