Clinical trial NCT05191784: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Glioblastoma
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Secondary outcomes:
measure: ORR (Objective response rate)
timeFrame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
measure: DOR (Duration of response)
timeFrame: From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.
measure: DCR (Disease control rate)
timeFrame: From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.
measure: Incidence of adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
measure: Immunogenicity (ADA)
timeFrame: Day 1 and Day 43 of each cycle (8-week interval)
measure: Immunogenicity (neutralizing antibody)
timeFrame: Day 1 and Day 43 of each cycle (8-week interval)
measure: Absolute counts and ratios of immune cell subtypes
timeFrame: Day 1 and Day 29 of each cycle (8-week interval)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital of the Catholic University of Korea
Study officials:
affiliation: Genexine, Inc.
name: Minkyu Heo
role: STUDY_DIRECTOR
References: