Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma

Newly Diagnosed Glioblastoma Clinical Trial

— GBM  

Official title:

A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619239
• Other study ID #: GX-I7-CA-004
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2018
• Est. completion date: September 25, 2020

Study information

• Verified date: March 2020
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be enrolled in two stages: - Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Description:

Detailed Description: • Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7 - pre-determined dose(Level I)~ pre-determined dose(Level IV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

[Inclusion Criteria]

1. Ability to understand and willingness to sign a written informed consent document (ICF).

2. Age = 19 years

3. Able to comply with the study protocol, in the investigator's judgment

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. [Exclusion Criteria] General Exclusion Criteria

1. Unable to comply with study and follow-up procedures

2. Is pregnant or breastfeeding

3. Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months

4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Related Conditions & MeSH terms

• Glioblastoma
• Newly Diagnosed Glioblastoma

Intervention

Drug:
• GX-I7
During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4~12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul	Seocho

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT(Dose-Limiting Toxicity) Assessment	Incidence and nature of DLT(Dose-Limiting Toxicity)s	Through study completion, an average of 2 years
Primary	Incidence, nature and severity of Adverse events	Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0	Through study completion, an average of 2 years
Secondary	PD(pharmacodynamic) profile [ALC result]	Changes of ALC(Absolute lymphocyte count) from the baseline	Through study completion, an average of 2 years
Secondary	Anti-tumor Activity [OS]	Objective response(OS) defined as the time from the date of diagnosis to the death from any cause	Through study completion, an average of 2 years
Secondary	Anti-tumor Activity [PFS]	Progression-free survival (PFS) defined according to iRANO(Immunotherapy Response Assessment for Neuro-Oncology)	Through study completion, an average of 2 years
Secondary	Immunogenicity[ ADA and neutralizing antibody]	Incidence of anti-GX-I7 antibody (ADA) and neutralizing antibody during the study	Through study completion, an average of 2 years
Secondary	Exploratory Biomarker [serum Interleukin-7]	Changes in serum Interleukin-7	Through study completion, an average of 2 years