Triple Negative Breast Cancer (TNBC)Phase 2NCT06586866
JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
A Phase 2 study testing JK-1201I in people with Triple Negative Breast Cancer (TNBC) and Brain Metastasases, run by JenKem Technology Co., Ltd..
Trial summary
This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC), Brain Metastasases
- What is being tested?
- JK-1201I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2024to 26 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.
Read the 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.
- Being tested
- JK-1201I
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK-1201IDrug
JK-1201I will be administered as an IV infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| JK-1201I | Experimental | 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. Receives: Drug: JK-1201I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 12 months.
Secondary outcomes (8)
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.
Measured: Up to approximately 12 months.
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.
Measured: Up to approximately 12 months.
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.
Measured: Up to approximately 6 months.
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.
Measured: Up to approximately 6 months.
Overall survival (OS)
Overall survival (OS) is defined as the time interval from randomization to death due to any cause.
Measured: Up to approximately 24 months.
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
Measured: Up to approximately 24 months.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
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.
Measured: Up to 6 months.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Sep 2024 (estimated)
- Primary completion26 May 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JenKem Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586866
- Sponsor's protocol ID
- JK-1201I-203
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06586866
- Acronym / sponsor ID
- JK-1201I-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- JenKem Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (estimated)
- Primary completion
- 26 May 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JK-1201I | Experimental | Drug: JK-1201IParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JK-1201IJK-1201I will be administered as an IV infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle. | Drug | JK-1201I |
Primary outcome
Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM
Time frame: 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.
8 secondary outcomes
Progression-free Survival (PFS) according to RECIST 1.1
Time frame: Up to approximately 12 months.
Progression-free Survival (PFS) according to RANO-BM
Time frame: Up to approximately 12 months.
Objective Response Rate (ORR) according to RECIST 1.1
Time frame: Up to approximately 6 months.
Objective Response Rate (ORR) according to RANO-BM
Time frame: Up to approximately 6 months.
Overall survival (OS)
Time frame: Up to approximately 24 months.
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
Time frame: Up to approximately 24 months.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Time frame: Up to 6 months.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Time frame: Up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JK-1201I in people with Triple Negative Breast Cancer (TNBC) and Brain Metastasases, run by JenKem Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahui SU (8610-82156767, yahuisu@jenkem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM (time frame: Up to approximately 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.