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

NCT03619239 | Completed Phase 1 DMC

• 1 other identifier: GX-I7-CA-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be enrolled in two stages:

• Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Conditions

Newly Diagnosed Glioblastoma

Keywords

Phase 1b

Outcome Measures

Primary Outcomes (2)

• DLT(Dose-Limiting Toxicity) Assessment

  Incidence and nature of DLT(Dose-Limiting Toxicity)s

  Through study completion, an average of 2 years

• 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 Outcomes (5)

• PD(pharmacodynamic) profile [ALC result]

  Through study completion, an average of 2 years

• Anti-tumor Activity [OS]

  Through study completion, an average of 2 years

• Anti-tumor Activity [PFS]

  Through study completion, an average of 2 years

• Immunogenicity[ ADA and neutralizing antibody]

  Through study completion, an average of 2 years

• Exploratory Biomarker [serum Interleukin-7]

  Through study completion, an average of 2 years

Study Arms (5)

Cohort 1

EXPERIMENTAL

Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.

Drug: GX-I7

Cohort 2

EXPERIMENTAL

Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.

Drug: GX-I7

Cohort 3

EXPERIMENTAL

Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.

Drug: GX-I7

Cohort 4

EXPERIMENTAL

Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.

Drug: GX-I7

Cohort 5(Dose-expansion)

EXPERIMENTAL

Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision)

Drug: GX-I7

Interventions

GX-I7 DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5(Dose-expansion)

Eligibility Criteria

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

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document (ICF).
• Age ≥ 19 years
• Able to comply with the study protocol, in the investigator's judgment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• Unable to comply with study and follow-up procedures
• Is pregnant or breastfeeding
• 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
• Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

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

Seoul, Seocho, 06591, South Korea

Location

MeSH Terms

Interventions

efineptakin alfa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 7, 2018
• Study Start: June 20, 2018
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-03

Locations

KR (1)