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

Официальное название

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

Обзор

This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM [Срок оценки: Up to approximately 12 months.]

Вторичные конечные точки (8)

• Progression-free Survival (PFS) according to RECIST 1.1 [Срок оценки: Up to approximately 12 months.]
• Progression-free Survival (PFS) according to RANO-BM [Срок оценки: Up to approximately 12 months.]
• Objective Response Rate (ORR) according to RECIST 1.1 [Срок оценки: Up to approximately 6 months.]
• Objective Response Rate (ORR) according to RANO-BM [Срок оценки: Up to approximately 6 months.]
• Overall survival (OS) [Срок оценки: Up to approximately 24 months.]
• Incidence and Grade of Participants with Adverse Events or Serious Adverse Events [Срок оценки: Up to approximately 24 months.]
• Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G [Срок оценки: Up to 6 months.]
• Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G [Срок оценки: Up to 6 months.]

Критерии участия

Inclusion

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.

Exclusion

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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06586866 · JK-1201I-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗