JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
- Conditions
- Triple Negative Breast Cancer (TNBC)Brain Metastasases
- Interventions
- Drug: JK-1201I
- Registration Number
- NCT06586866
- Lead Sponsor
- JenKem Technology Co., Ltd.
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JK-1201I 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.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM Up to approximately 12 months. Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) according to RECIST 1.1 Up to approximately 12 months. Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Progression-free Survival (PFS) according to RANO-BM Up to approximately 12 months. Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Objective Response Rate (ORR) according to RECIST 1.1 Up to approximately 6 months. Confirmed ORR is defined as the proportion of participants who have achieved a best overall response of confirmed complete response (CR), confirmed partial response (PR) according to RECIST 1.1.
Objective Response Rate (ORR) according to RANO-BM Up to approximately 6 months. Confirmed ORR is defined as the proportion of participants who have achieved a best overall response of confirmed complete response (CR), confirmed partial response (PR) according to RANO-BM.
Overall survival (OS) Up to approximately 24 months. Overall survival (OS) is defined as the time interval from randomization to death due to any cause.
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events Up to approximately 24 months. Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G Up to 6 months. Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using Non-linear mixed effect modeling.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G Up to 6 months. Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.