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Not yet recruitingNCT06586866Updated Sep 19, 2024

JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases

A Phase 2 interventional study of JK-1201I in Triple Negative Breast Cancer (TNBC) and Brain Metastasases, sponsored by JenKem Technology Co., Ltd.. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by JenKem Technology Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Triple Negative Breast Cancer (TNBC)
  • Brain Metastasases
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 25 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

JenKem Technology Co., Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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 criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: JK-1201I

Interventions

  • DrugJK-1201I

    JK-1201I will be administered as an IV infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle.

06

What researchers measure

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.

  5. Overall survival (OS)

    Overall survival (OS) is defined as the time interval from randomization to death due to any cause.

    Time frame: Up to approximately 24 months.

  6. 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.

    Time frame: Up to approximately 24 months.

  7. 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.

    Time frame: Up to 6 months.

  8. Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G

    Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.

    Time frame: Up to 6 months.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06586866
Lead sponsor
JenKem Technology Co., Ltd.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 26, 2024 (estimated)
Primary completion
May 26, 2026 (estimated)
Completion
Oct 26, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Yahui SU
Contact
yahuisu@jenkem.com
8610-82156767

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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