Actively Recruiting
JK-1201I Combined with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma Multiforme After Surgery and Radio-chemotherapy Phase 2 Study
Led by JenKem Technology Co., Ltd. · Updated on 2024-09-19
25
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes JK-1201I combined with adjuvant temozolomide in patients newly diagnosed with glioblastoma multiforme (GBM) after surgery and combined radio-chemotherapy. This phase 2, multicenter, single arm, open-label study focuses on patients who have had surgery and are completing standard initial treatments for GBM. Participants receive JK-1201I as an intravenous infusion every 14 days in cycles, with doses gradually increased in a dose-escalation phase and then given at a recommended dose in an expansion phase. Temozolomide is administered alongside JK-1201I following the usual dosing guidelines. Treatment continues until disease progression or other criteria for stopping treatment are met. During the study, participants will be monitored for adverse events and serious side effects for up to 12 months, with evaluations of tumor progression and overall survival also assessed within the same period. Blood samples will be collected over six months to study how JK-1201I and related compounds behave in the body. Participants must meet specific health and functional criteria and will be followed regularly to assess treatment effects and safety throughout the trial duration.
CONDITIONS
Brief Title
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Newly diagnosed glioblastoma confirmed by imaging or pathology with gross total resection of 80% or more
- Completed concurrent chemo-radiotherapy between 4 and 6 weeks ago
- Stable or reduced corticosteroid dose for more than 2 weeks
- Karnofsky performance score of 70 or higher
- Life expectancy greater than 12 weeks
- Adequate biological function
- Use of effective contraceptive methods during the study and for 6 months after last dose
- Signed informed consent form
- MGMT unmethylation status required for Dose Expansion Cohort
You will not qualify if you...
- Prior anti-tumor therapy other than concurrent chemo-radiotherapy
- Primary brain stem or spinal cord tumor diagnosis
- Hypersensitivity to JK-1201I ingredients
- Severe or uncontrolled cardiovascular disease in past 6 months
- Inability to take oral medication or significant gastrointestinal abnormalities
- Uncontrolled seizures
- Use of prohibited medications that cannot be stopped 2 weeks before treatment
- Severe or uncontrolled high blood pressure
- Unresolved toxicity from prior anti-tumor therapy
- Pregnant or breastfeeding women
- Positive HIV antibody or active hepatitis B or C infection
- Participation in another clinical trial within 4 weeks before consent
- History of mental disorders
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive JK-1201I combined with adjuvant temozolomide until disease progression.
Visits every 2 weeks for JK-1201I infusion; temozolomide administered per drug label
Duration - Up to 12 months
Participants are monitored for safety and survival outcomes for up to 12 months after treatment.
Regular visits for safety and survival assessments
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yahui SU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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