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

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ClinicalTrials.gov Identifier: NCT05191784
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: GX-I7 Drug: Bevacizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
Actual Study Start Date : December 27, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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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:
  • rhIL-7-hyFc
  • Efineptakin alfa

Drug: Bevacizumab
Administered by intravenous (IV) injection
Other Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Immunogenicity (ADA) [ Time Frame: Day 1 and Day 43 of each cycle (8-week interval) ]
    The incidence rate of anti-drug antibodies (ADAs)

  6. 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)

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191784


Contacts
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Contact: Minkyu Heo 82-31-628-3340 mkheo@genexine.com

Locations
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Korea, Republic of
Seoul St.Mary's Hospital of the Catholic University of Korea Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Sin-Soo Jeon, M.D.    82)2-2258-7535    ssjeun@catholic.ac.kr   
Principal Investigator: Sin-Soo Jeon, M.D.         
Sub-Investigator: Stephen Ahn, M.D.         
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Study Director: Minkyu Heo Genexine, Inc.
More Information
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT05191784    
Other Study ID Numbers: GX-I7-CA-010
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors