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.
This is 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 Patients will receive JK-1201I combined with temozolomide until disease progression. The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy. The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
JK-1201I will be administered.
Temozolomide will be administered.
Beijing Tiantan Hospital
Beijing, China
RECRUITINGIncidence and Grade of Participants with Adverse Events or Serious Adverse Events
Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
Time frame: From the date of first dose to the end of safety follow-up; Up to 12 months.
Progression-free Survival (PFS) Assessed by Investigators
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.
Overall survival (OS)
Overall survival (OS) is defined as the time interval from randomization to death due to any cause.
Time frame: From the date of randomization to the date of death due to any cause; Up to 12 months.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using Non-linear mixed effect modeling.
Time frame: Up to 6 months.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.
Time frame: Up to 6 months.
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