JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)

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JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06595186
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	JenKem Technology Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme (GBM)

Additional Details

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.

Arms & Interventions

Arms

Experimental: Dose Escalation Cohort

Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design. Temozolomide will be administered per drug label.

Experimental: Dose Expansion Cohort

Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Temozolomide will be administered per drug label.

Interventions

Drug: - JK-1201I

JK-1201I will be administered.

Drug: - Temozolomide (TMZ)

Temozolomide will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.