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

NCT04065087 | Withdrawn Phase 1 DMC

• 1 other identifier: GX-I7-CA-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Newly Diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• lymphocyte count

  Change in absolute lymphocyte count

  12 weeks

Secondary Outcomes (2)

• Overall survival

  36 months

• Progression free survival

  24 months

Study Arms (2)

GX-I7

EXPERIMENTAL

GX-I7 administered until Progression of Disease

Biological: GX-I7

Placebo

PLACEBO COMPARATOR

Placebo administered until Progression of Disease

Other: Placebo

Interventions

GX-I7 BIOLOGICAL

Investigational drug

GX-I7

Placebo OTHER

Placebo drug

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF)
• Age ≥ 19 years
• 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)
• Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
• Karnofsky score ≥ 60
• Life expectancy \> 12 weeks

You may not qualify if:

• Gliomatosis cerebri
• Isocitrate dehydrogenase 1 \& 2 mutation
• Pregnant or breast feeding women

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

St. Vincent Hospital

Suwon, South Korea

Location

MeSH Terms

Interventions

efineptakin alfa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 22, 2019
• Study Start: August 22, 2019
• Primary Completion: May 27, 2022
• Study Completion: August 27, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)