Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma

Phase 1

Withdrawn

• Conditions: Newly Diagnosed Glioblastoma
• Interventions: Biological: GX-I7; Other: Placebo

• Registration Number: NCT04065087
• Lead Sponsor: Genexine, Inc.

Brief Summary

This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)

Detailed Description

In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose.

Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-08-21
• Study Start: 2019-08-22
• Study First Posted: 2019-08-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-05-27
• Study Completion: 2022-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Signed Informed Consent Form (ICF)
2. Age ≥ 19 years
3. Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
4. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
5. Karnofsky score ≥ 60
6. Life expectancy > 12 weeks

Exclusion Criteria

1. Gliomatosis cerebri
2. Isocitrate dehydrogenase 1 & 2 mutation
3. Pregnant or breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GX-I7	GX-I7	GX-I7 administered until Progression of Disease
Placebo	Placebo	Placebo administered until Progression of Disease

Primary Outcome Measures

Name	Time	Method
lymphocyte count	12 weeks	Change in absolute lymphocyte count

Secondary Outcome Measures

Name	Time	Method
Overall survival	36 months	Median overall survival
Progression free survival	24 months	Median progression free survival

Trial Locations

Locations (1)

St. Vincent Hospital; 🇰🇷 Suwon-si, Korea, Republic of