Status:
RECRUITING
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
Lead Sponsor:
JenKem Technology Co., Ltd.
Conditions:
Glioblastoma Multiforme (GBM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 aft...
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 surger...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06595186
Start Date
October 31 2022
End Date
December 16 2026
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tiantan Hospital
Beijing, China