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

NCT06586866 | Not Yet Recruiting Phase 2

• 1 other identifier: JK-1201I-203
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Triple Negative Breast Cancer (TNBC); Brain Metastasases

Outcome Measures

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.

  Up to approximately 12 months.

Secondary Outcomes (8)

• Progression-free Survival (PFS) according to RECIST 1.1

  Up to approximately 12 months.

• Progression-free Survival (PFS) according to RANO-BM

  Up to approximately 12 months.

• Objective Response Rate (ORR) according to RECIST 1.1

  Up to approximately 6 months.

• Objective Response Rate (ORR) according to RANO-BM

  Up to approximately 6 months.

• Overall survival (OS)

  Up to approximately 24 months.

Study Arms (1)

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.

Drug: JK-1201I

Interventions

JK-1201I DRUG

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

JK-1201I

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• JenKem Technology Co., Ltd.: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yahui SU

CONTACT

8610-82156767; yahuisu@jenkem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09