GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

NCT ID: NCT05191784

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

Detailed Description

This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GX-I7 and bevacizumab

Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: DRUG

Administered by intramuscular (IM) injection

Bevacizumab

Intervention Type: DRUG

Administered by intravenous (IV) injection

Interventions

GX-I7

Administered by intramuscular (IM) injection

Intervention Type: DRUG

Bevacizumab

Administered by intravenous (IV) injection

Intervention Type: DRUG

Other Intervention Names

rhIL-7-hyFc; Efineptakin alfa; Avastin

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 19 years

2. Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))

3. Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2

4. Life expectancy > 12 weeks

5. Adequate hematologic and end organ function

Exclusion Criteria

1. Malignancies other than disease under study within 5 years prior to the first dose of study drug

2. Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation

3. Body Mass Index (BMI) ≥ 30 kg/m2

4. Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI

5. Clinically significant cardiovascular disease

6. History of arterial or venous thromboembolism 6 months prior to study participation

7. Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)

8. History of hypertensive crisis or hypertensive encephalopathy

9. Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)

10. Pregnancy or breastfeeding.

11. Subjects with active virus infection

12. Subjects with autoimmune disease/ syndromes

13. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study

14. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

15. Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia

16. Prior allogeneic bone marrow transplantation or prior solid organ transplantation

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkyu Heo

Role: STUDY_DIRECTOR

Genexine, Inc.

Locations

Seoul St.Mary's Hospital of the Catholic University of Korea

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GX-I7-CA-010

Identifier Type: -

Identifier Source: org_study_id