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

NCT05191784 | Unknown Phase 2

• 1 other identifier: GX-I7-CA-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• ORR (Objective response rate)

  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)

  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)

  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)

  Through study completion, an average of 1 year

• Immunogenicity (ADA)

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

Study Arms (1)

GX-I7 and bevacizumab

EXPERIMENTAL

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

Drug: GX-I7; Drug: Bevacizumab

Interventions

GX-I7 DRUG

Administered by intramuscular (IM) injection

Also known as: rhIL-7-hyFc, Efineptakin alfa

GX-I7 and bevacizumab

Bevacizumab DRUG

Administered by intravenous (IV) injection

Also known as: Avastin

GX-I7 and bevacizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

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

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

efineptakin alfa; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Minkyu Heo

  Genexine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: January 13, 2022
• Study Start: January 26, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)