Actively Recruiting
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
Led by JenKem Technology Co., Ltd. · Updated on 2024-09-19
25
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 years 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 prior
- Stable or reduced corticosteroid dose for more than 2 weeks
- Karnofsky score of 70 or higher
- Life expectancy greater than 12 weeks
- Adequate biological function
- Use of adequate contraceptive methods during the study and for 6 months after last dose
- Signed and dated informed consent form
- MGMT unmethylation for Dose Expansion Cohort only
You will not qualify if you...
- Received anti-tumor therapy other than concurrent chemo-radiotherapy
- Primary tumor located in brain stem or spinal cord
- Hypersensitivity to any ingredient of JK-1201I
- Severe, uncontrolled, or active cardiovascular diseases within past 6 months
- Unable to take oral medication or have significant gastrointestinal issues affecting absorption
- Uncontrolled seizures
- Receiving prohibited medications that cannot be stopped at least 2 weeks before treatment
- Severe or uncontrolled high blood pressure
- Unresolved toxicity from prior anti-tumor therapy
- Pregnant or breastfeeding women
- Positive for HIV antibody or active hepatitis B or C infection
- Participated in another clinical trial within 4 weeks before informed consent
- History of mental disorders
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yahui SU
CONTACT
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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