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

June 8, 2023 updated by: Genexine, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Seoul St.Mary's Hospital of the Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GX-I7 and bevacizumab
Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.
Drug: GX-I7
Administered by intramuscular (IM) injection
Other Names:
  • Efineptakin alfa
  • rhIL-7-hyFc
Drug: Bevacizumab
Administered by intravenous (IV) injection
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
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.
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.
Overall survival (OS)
Time Frame: From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Overall survival (OS)
From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (Objective response rate)
Time Frame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
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.
DOR (Duration of response)
Time Frame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
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.
DCR (Disease control rate)
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.
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.
Incidence of adverse events (AEs)
Time Frame: Through study completion, an average of 1 year
The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0
Through study completion, an average of 1 year
Immunogenicity (ADA)
Time Frame: Day 1 and Day 43 of each cycle (8-week interval)
The incidence rate of anti-drug antibodies (ADAs)
Day 1 and Day 43 of each cycle (8-week interval)
Immunogenicity (neutralizing antibody)
Time Frame: Day 1 and Day 43 of each cycle (8-week interval)
The incidence rate of anti-drug antibodies (neutralizing antibody)
Day 1 and Day 43 of each cycle (8-week interval)
Absolute counts and ratios of immune cell subtypes
Time Frame: Day 1 and Day 29 of each cycle (8-week interval)
Changes of absolute counts and ratios of immune cell subtypes
Day 1 and Day 29 of each cycle (8-week interval)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genexine, Inc.

Investigators

  • Study Director: Minkyu Heo, Genexine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX-I7-CA-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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