JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JK-1201I, Temozolomide (TMZ).
- Who it may be relevant to
- Registry conditions: Glioblastoma Multiforme (GBM). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug JK-1201I
JK-1201I will be administered. - Drug Temozolomide (TMZ)
Temozolomide will be administered.
Primary outcome measures
- Incidence and Grade of Participants with Adverse Events or Serious Adverse Events [Time frame: From the date of first dose to the end of safety follow-up; Up to 12 months.]
Secondary outcome measures (4)
- Progression-free Survival (PFS) Assessed by Investigators [Time frame: 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) [Time frame: 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 [Time frame: Up to 6 months.]
- Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G [Time frame: Up to 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT06595186 · JK-1201I-202