NCT06586866

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: JenKem Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer (TNBC)
• Brain Metastasases

Interventions

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

Timeline

• Start date: 2024-09-26
• Primary completion: 2026-05-26
• Completion: 2026-10-26
• First posted: 2024-09-19
• Last updated: 2024-09-19