Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
- Registration Number
- NCT03619239
- Lead Sponsor
- Genexine, Inc.
- Brief Summary
Patients will be enrolled in two stages:
* Dose-escalation stage: Approximately 12-24 patients will be enrolled.
- Detailed Description
Detailed Description:
• Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7
* pre-determined dose(Level I)\~ pre-determined dose(Level IV)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 2 GX-I7 Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle. Cohort 5(Dose-expansion) GX-I7 Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision) Cohort 1 GX-I7 Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle. Cohort 3 GX-I7 Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle. Cohort 4 GX-I7 Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
- Primary Outcome Measures
Name Time Method Incidence, nature and severity of Adverse events Through study completion, an average of 2 years Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0
DLT(Dose-Limiting Toxicity) Assessment Through study completion, an average of 2 years Incidence and nature of DLT(Dose-Limiting Toxicity)s
- Secondary Outcome Measures
Name Time Method Exploratory Biomarker [serum Interleukin-7] Through study completion, an average of 2 years Changes in serum Interleukin-7
PD(pharmacodynamic) profile [ALC result] Through study completion, an average of 2 years Changes of ALC(Absolute lymphocyte count) from the baseline
Anti-tumor Activity [OS] Through study completion, an average of 2 years Objective response(OS) defined as the time from the date of diagnosis to the death from any cause
Anti-tumor Activity [PFS] Through study completion, an average of 2 years Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)
Immunogenicity[ ADA and neutralizing antibody] Through study completion, an average of 2 years Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study
Trial Locations
- Locations (1)
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seocho, Korea, Republic of