Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT03478995

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2020-03-16

Brief Summary

Patients will be enrolled in two stages:

• Dose-escalation stage: Approximately 15-30 patients will be enrolled.
• Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.

Detailed Description

• Dose-escalation stage : designed as classical 3+3 to determine MTD or RP2D to evaluate approximately GX-I7.
• Dose-expansion stage : designed to enroll additional 6-12 patients to acquire additional safety and pharmacodynamic data to more fully inform the dose selection for RP2D

Conditions

Locally Advanced or Metastatic Solid Tumors

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GX-I7

Determined dose of GX-I7 on Day1 of each cycle

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: DRUG

GX-I7 25mg/ml/vial

Interventions

GX-I7

GX-I7 25mg/ml/vial

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent Form (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
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)
• Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to Cycle 1, Day 1
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
• Patients with histologic documentation of locally advanced, recurrent, or metastatic incurable solid tumors that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate
• Patients with measurable disease per RECIST v1.1

Exclusion Criteria

• Inability to comply with study and follow-up procedures
• Pregnancy, lactation, or breastfeeding
• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
• Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L)
• Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study
• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
• History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• Primary CNS malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joo Hyuk Sohn, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital

Tae Won Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Oncology, Asan Medical Center

Myoung-Ah Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Oncology, Seoul St. Mary's Hospital, of the Catholic University

Locations

Severance Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

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

Seoul, , South Korea

Countries

South Korea

References

Kim GM, Kim S, Lee MA, Byun MS, Choi D, Yang SH, Woo J, Sung YC, Shin EC, Park SH, Kim TW, Sohn J. GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8+/CD4+ T cells and TILs in patients with locally advanced or metastatic solid tumours. Br J Cancer. 2025 Sep;133(4):524-532. doi: 10.1038/s41416-025-03069-3. Epub 2025 Jun 9.

Reference Type: DERIVED

PMID: 40490502 (View on PubMed)

Other Identifiers

GX-I7-CA-003

Identifier Type: -

Identifier Source: org_study_id