GX-I7 in Combination With Bevacizumab in Recurrent Gliobl... | NCT05191784

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

NCT05191784

Sponsor

Genexine, Inc.

Status

Unknown status

Last Update Posted

Jun 12, 2023Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Recurrent Glioblastoma

Interventions

GX-I7
Bevacizumab

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Nov 10, 2021

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
GX-I7 and bevacizumab	Experimental	Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.	Drug: GX-I7 Drug: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
GX-I7	Drug	Administered by intramuscular (IM) injection	GX-I7 and bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
ORR (Objective response rate)	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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

ID	Term
C000712767	efineptakin alfa
D000068258	Bevacizumab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins