Tests JK-1201I with temozolomide in newly diagnosed glioblastoma
Tests JK-1201I with temozolomide in adults newly diagnosed with glioblastoma.
Plain-language title generated from the registry record
Registry title: JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed glioblastoma who have had surgery and finished radiation with chemotherapy. They would then get JK-1201I with temozolomide.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Newly diagnosed glioblastoma (diagnosed by imaging or pathology testing), with at least 80% of the tumour removed in surgery. Karnofsky score of at least 70 and life expectancy over 12 weeks.
- Earlier treatment
- Must have finished radiation with chemotherapy 4 to 6 weeks earlier. No other anti-tumor treatment before. Corticosteroid dose stable or reduced for more than 2 weeks.
- Biomarker or test result
- For the dose expansion part only: MGMT unmethylation.
Main reasons for not taking part
- Brain stem or spinal cord tumor as the main tumor
- Uncontrolled seizures
- Severe or active heart disease in the past 6 months
- Pregnant or breast-feeding
- Positive HIV antibody, or active hepatitis B or hepatitis C infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06595186, who can take part
Where in China
- Beijing Tiantan HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- JenKem Technology Co., Ltd.
- Trial code
- NCT06595186
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
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
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.
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; Have participated in another clinical trial within 4 weeks prior to informed consent form; History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.