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

Recurrent Glioblastoma Clinical Trial

Official title:

A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05191784
• Other study ID #: GX-I7-CA-010
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

Drug:
• GX-I7
Administered by intramuscular (IM) injection
• Bevacizumab
Administered by intravenous (IV) injection

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital of the Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression free survival (PFS) by iRANO criteria	From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Primary	Overall survival (OS)	Overall survival (OS)	From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Secondary	ORR (Objective response rate)	ORR (Objective response rate) by iRANO criteria	From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
Secondary	DOR (Duration of response)	DOR (Duration of response) by iRANO criteria	From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
Secondary	DCR (Disease control rate)	DCR (Disease control rate) by iRANO criteria	From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.
Secondary	Incidence of adverse events (AEs)	The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0	Through study completion, an average of 1 year
Secondary	Immunogenicity (ADA)	The incidence rate of anti-drug antibodies (ADAs)	Day 1 and Day 43 of each cycle (8-week interval)
Secondary	Immunogenicity (neutralizing antibody)	The incidence rate of anti-drug antibodies (neutralizing antibody)	Day 1 and Day 43 of each cycle (8-week interval)
Secondary	Absolute counts and ratios of immune cell subtypes	Changes of absolute counts and ratios of immune cell subtypes	Day 1 and Day 29 of each cycle (8-week interval)