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

Primary Purpose

Recurrent Glioblastoma

Status

Active

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GX-I7

Bevacizumab

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 19 years
Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
Life expectancy > 12 weeks
Adequate hematologic and end organ function

Exclusion Criteria:

Malignancies other than disease under study within 5 years prior to the first dose of study drug
Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
Body Mass Index (BMI) ≥ 30 kg/m2
Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
Clinically significant cardiovascular disease
History of arterial or venous thromboembolism 6 months prior to study participation
Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
History of hypertensive crisis or hypertensive encephalopathy
Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
Pregnancy or breastfeeding.
Subjects with active virus infection
Subjects with autoimmune disease/ syndromes
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
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
Prior allogeneic bone marrow transplantation or prior solid organ transplantation

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GX-I7 and bevacizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Progression free survival (PFS) by iRANO criteria

Overall survival (OS)

Secondary Outcome Measures

ORR (Objective response rate)

ORR (Objective response rate) by iRANO criteria

DOR (Duration of response)

DOR (Duration of response) by iRANO criteria

DCR (Disease control rate)

DCR (Disease control rate) by iRANO criteria

Incidence of adverse events (AEs)

The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0

Immunogenicity (ADA)

The incidence rate of anti-drug antibodies (ADAs)

Immunogenicity (neutralizing antibody)

The incidence rate of anti-drug antibodies (neutralizing antibody)

Absolute counts and ratios of immune cell subtypes

Changes of absolute counts and ratios of immune cell subtypes

Full Information

NCT ID

NCT05191784

First Posted

November 10, 2021

Last Updated

June 8, 2023

Sponsor

Genexine, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05191784

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 26, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genexine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GX-I7 and bevacizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GX-I7

Other Intervention Name(s)

rhIL-7-hyFc, Efineptakin alfa

Intervention Description

Administered by intramuscular (IM) injection

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Administered by intravenous (IV) injection

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Progression free survival (PFS) by iRANO criteria

Time Frame

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.

Title

Overall survival (OS)

Description

Overall survival (OS)

Time Frame

From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.

Secondary Outcome Measure Information:

Title

ORR (Objective response rate)

Description

ORR (Objective response rate) by iRANO criteria

Time Frame

From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.

Title

DOR (Duration of response)

Description

DOR (Duration of response) by iRANO criteria

Time Frame

From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.

Title

DCR (Disease control rate)

Description

DCR (Disease control rate) by iRANO criteria

Time Frame

From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.

Title

Incidence of adverse events (AEs)

Description

The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0

Time Frame

Through study completion, an average of 1 year

Title

Immunogenicity (ADA)

Description

The incidence rate of anti-drug antibodies (ADAs)

Time Frame

Day 1 and Day 43 of each cycle (8-week interval)

Title

Immunogenicity (neutralizing antibody)

Description

The incidence rate of anti-drug antibodies (neutralizing antibody)

Time Frame

Day 1 and Day 43 of each cycle (8-week interval)

Title

Absolute counts and ratios of immune cell subtypes

Description

Changes of absolute counts and ratios of immune cell subtypes

Time Frame

Day 1 and Day 29 of each cycle (8-week interval)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 19 years Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ)) Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2 Life expectancy > 12 weeks Adequate hematologic and end organ function Exclusion Criteria: Malignancies other than disease under study within 5 years prior to the first dose of study drug Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation Body Mass Index (BMI) ≥ 30 kg/m2 Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI Clinically significant cardiovascular disease History of arterial or venous thromboembolism 6 months prior to study participation Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy) History of hypertensive crisis or hypertensive encephalopathy Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin) Pregnancy or breastfeeding. Subjects with active virus infection Subjects with autoimmune disease/ syndromes 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 History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia Prior allogeneic bone marrow transplantation or prior solid organ transplantation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minkyu Heo

Organizational Affiliation

Genexine, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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