NCT06595186

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: JenKem Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme (GBM)

Interventions

Type	Name	Description
DRUG	JK-1201I	JK-1201I will be administered.
DRUG	Temozolomide (TMZ)	Temozolomide will be administered.

Timeline

• Start date: 2022-10-31
• Primary completion: 2026-08-16
• Completion: 2026-12-16
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China