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Trial Title:
JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
NCT ID:
NCT06586866
Condition:
Triple Negative Breast Cancer (TNBC)
Brain Metastasases
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JK-1201I
Description:
JK-1201I will be administered as an IV infusion at dose of 125mg/m2 on Day 1 of each
14-day cycle.
Arm group label:
JK-1201I
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 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.
Criteria for eligibility:
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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 26, 2024
Completion date:
October 26, 2026
Lead sponsor:
Agency:
JenKem Technology Co., Ltd.
Agency class:
Industry
Source:
JenKem Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06586866
