NCT06595186 JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
| NCT ID | NCT06595186 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | JenKem Technology Co., Ltd. |
| Condition | Glioblastoma Multiforme (GBM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2026-08-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2022-10-31 with a primary completion date of 2026-08-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 after surgery and concomitant radio-chemotherapy.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06595186 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Glioblastoma Multiforme (GBM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06595186 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06595186 currently recruiting?
Yes, NCT06595186 is actively recruiting participants. Contact the research team at yahuisu@jenkem.com for enrollment information.
Where is the NCT06595186 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06595186 clinical trial?
NCT06595186 is sponsored by JenKem Technology Co., Ltd.. The trial plans to enroll 25 participants.
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