RecruitingPhase 2NCT06595186

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

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


Sponsor

JenKem Technology Co., Ltd.

Enrollment

25 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called JK-1201I combined with the standard chemotherapy drug temozolomide in patients with newly diagnosed glioblastoma (an aggressive brain cancer) after they complete standard chemoradiation. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with glioblastoma (confirmed by imaging or pathology) - At least 80% of your tumor was removed during surgery - You have completed concurrent chemoradiation therapy between 4 and 6 weeks ago - Your steroid dose has been stable or decreasing for at least 2 weeks - Your general health and organ function are adequate (Karnofsky score 70 or above) - For one part of the study: your tumor must have MGMT unmethylation (a specific tumor characteristic) **You may NOT be eligible if...** - You received any other anti-cancer therapy besides chemoradiation - Your tumor is in the brain stem or spinal cord - You are allergic to JK-1201I ingredients - You have serious uncontrolled heart problems - You have uncontrolled seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJK-1201I

JK-1201I will be administered.

DRUGTemozolomide (TMZ)

Temozolomide will be administered.


Locations(1)

Beijing Tiantan Hospital

Beijing, China

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NCT06595186


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