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

ConditionGlioblastoma 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • JK-1201I

    Drug

    JK-1201I will be administered.

  • Temozolomide (TMZ)

    Drug

    Temozolomide will be administered.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Dose Escalation CohortExperimental treatment 2 interventions
Group B: Dose Expansion CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence 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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JenKem Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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