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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJenKem Technology Co., Ltd.

About this trial

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

Qualifiers

Male or female aged ≥18 years and ≤75 years.

Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.

Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.

Stable dose or reduced dose of corticosteroid for more than 2 weeks.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • JK-1201I
  • Temozolomide (TMZ)

Treatment groups

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators