Combining JK-1201I with Temozolomide for Newly Diagnosed Glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tiantan Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yahui SU
• Email: yahuisu@jenkem.com
• Phone: 8610-82156767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.