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

Phase 2

Recruiting

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Dose Expansion Cohort	Temozolomide (TMZ)	Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Temozolomide will be administered per drug label.
Dose Escalation Cohort	JK-1201I	Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design. Temozolomide will be administered per drug label.
Dose Escalation Cohort	Temozolomide (TMZ)	Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design. Temozolomide will be administered per drug label.
Dose Expansion Cohort	JK-1201I	Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Temozolomide will be administered per drug label.

Primary Outcome Measures

Name	Time	Method
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events	From the date of first dose to the end of safety follow-up; Up to 12 months.	Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) Assessed by Investigators	From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.	Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Overall survival (OS)	From the date of randomization to the date of death due to any cause; Up to 12 months.	Overall survival (OS) is defined as the time interval from randomization to death due to any cause.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G	Up to 6 months.	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.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G	Up to 6 months.	Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.