Temozolomide (TMZ): Temozolomide will be administered.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion
Participants must meet all the following criteria to be eligible for randomization into the study:
1. Male or female aged ≥18 years and ≤75 years.
2. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.
3. Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.
4. Stable dose or reduced dose of corticosteroid for more than 2 weeks.
5. Karnofsky score ≥ 70.
6. Life expectancy \> 12 weeks.
7. Adequate biological function.
8. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.
9. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
10. MGMT unmethylation (only for Dose Expansion Cohort).
Exclusion
Participants who meet any of the following criteria will be disqualified from entering the study:
1. Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).
2. Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.
3. Hypersensitivity to any ingredient of JK-1201I.
4. Severe, uncontrolled or active cardiovascular diseases within the past 6 months.
5. Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
6. Uncontrolled seizures.
7. Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.
8. Severe or uncontrolled high blood pressure.
9. Unresolved toxicity from prior anti-tumor therapy.
10. 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.
Primary outcome measure(s)
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events — From the date of first dose to the end of safety follow-up; Up to 12 months. Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.