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Trial Title:
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
NCT ID:
NCT06595186
Condition:
Glioblastoma Multiforme (GBM)
Conditions: Official terms:
Glioblastoma
Temozolomide
Conditions: Keywords:
glioblastoma multiforme
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JK-1201I
Description:
JK-1201I will be administered.
Arm group label:
Dose Escalation Cohort
Arm group label:
Dose Expansion Cohort
Intervention type:
Drug
Intervention name:
Temozolomide (TMZ)
Description:
Temozolomide will be administered.
Arm group label:
Dose Escalation Cohort
Arm group label:
Dose Expansion Cohort
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.
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 surgery and concomitant radio-chemotherapy Patients will receive
JK-1201I combined with temozolomide until disease progression.
The primary objective of this study is to assess the safety of JK-1201I combined with
adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after
surgery and concomitant radio-chemotherapy.
The secondary objectives of the study are to further evaluate the efficacy and
pharmacokinetic profiles of JK-1201I.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin LI
Phone:
8610-82156767
Email:
yahuisu@jenkem.com
Start date:
October 31, 2022
Completion date:
December 16, 2026
Lead sponsor:
Agency:
JenKem Technology Co., Ltd.
Agency class:
Industry
Source:
JenKem Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595186
