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

A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04065087

Enrollment

Registered

2019-08-22

Start date

2019-08-22

Completion date

2022-08-27

Last updated

2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Glioblastoma

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.

Interventions

BIOLOGICALGX-I7

Investigational drug

OTHERPlacebo

Placebo drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
lymphocyte count	12 weeks	Change in absolute lymphocyte count

Secondary

Measure	Time frame	Description
Overall survival	36 months	Median overall survival
Progression free survival	24 months	Median progression free survival

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026