JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJenKem Technology Co., Ltd.
About this trial
This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
JK-1201I
DrugJK-1201I will be administered as an IV infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: JK-1201IExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Time frame
Up to approximately 12 months.Secondary outcomes
1
Progression-free Survival (PFS) according to RECIST 1.1
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Time frame
Up to approximately 12 months.2
Progression-free Survival (PFS) according to RANO-BM
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Time frame
Up to approximately 12 months.3
Objective Response Rate (ORR) according to RECIST 1.1
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.
Time frame
Up to approximately 6 months.4
Objective Response Rate (ORR) according to RANO-BM
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.
Time frame
Up to approximately 6 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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