JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)

Официальное название

A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy

Обзор

This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

Подробное описание

This is a multicenter, single arm, open-label, dose-escalation phase 2 study of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) after surgery and concomitant radio-chemotherapy Patients will receive JK-1201I combined with temozolomide until disease progression.

The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.

Вмешательства

• Препарат JK-1201I
  JK-1201I will be administered.
• Препарат Temozolomide (TMZ)
  Temozolomide will be administered.

Первичные конечные точки

• Incidence and Grade of Participants with Adverse Events or Serious Adverse Events [Срок оценки: From the date of first dose to the end of safety follow-up; Up to 12 months.]

Вторичные конечные точки (4)

• Progression-free Survival (PFS) Assessed by Investigators [Срок оценки: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.]
• Overall survival (OS) [Срок оценки: From the date of randomization to the date of death due to any cause; Up to 12 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:

• Male or female aged ≥18 years and ≤75 years.
• Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.
• Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.
• Stable dose or reduced dose of corticosteroid for more than 2 weeks.
• Karnofsky score ≥ 70.
• Life expectancy \> 12 weeks.
• 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.
• Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• MGMT unmethylation (only for Dose Expansion Cohort).

Exclusion

Participants who meet any of the following criteria will be disqualified from entering the study:

• Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).
• Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.
• Hypersensitivity to any ingredient of JK-1201I.
• Severe, uncontrolled or active cardiovascular diseases within the past 6 months.
• Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
• Uncontrolled seizures.
• Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.
• Severe or uncontrolled high blood pressure.
• Unresolved toxicity from prior anti-tumor therapy.
• Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.

12\. Have participated in another clinical trial within 4 weeks prior to informed consent form.

13\. History of mental disorders. 14. 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

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06595186 · JK-1201I-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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