Combining JK-1201I with Temozolomide for Newly Diagnosed Glioblastoma

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

This study is testing if adding a new drug called JK-1201I to the standard treatment of temozolomide can help people who have just been diagnosed with glioblastoma feel better and live longer after their surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: JenKem Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06595186 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety, tolerability, efficacy, and pharmacokinetics of JK-1201I when combined with adjuvant temozolomide in patients who have recently been diagnosed with glioblastoma multiforme (GBM) following surgery and concomitant radio-chemotherapy. The study is multicenter, single-arm, and open-label, allowing for a thorough assessment of the treatment's effects until disease progression occurs. Participants will receive the combination therapy after completing their initial treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed glioblastoma who have undergone significant surgical resection and completed concurrent chemo-radiotherapy.

Not a fit: Patients with a Karnofsky score below 70 or those who have not completed the required prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed glioblastoma multiforme.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in combining targeted therapies with standard treatments for glioblastoma.

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yahui SU

Conditions Glioblastoma Multiforme; glioblastoma multiforme