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

Genexine

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Newly Diagnosed Glioblastoma

Treatments: Biological: GX-I7; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04065087

GX-I7-CA-007

Details and patient eligibility

About

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)

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

GX-I7

Experimental group

Description:

GX-I7 administered until Progression of Disease

Treatment:

Biological: GX-I7

Placebo

Placebo Comparator group

Description:

Placebo administered until Progression of Disease

Treatment:

Other: Placebo