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

NCT03478995 | Completed Phase 1 DMC

• 1 other identifier: GX-I7-CA-003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

Phase1b

Outcome Measures

Primary Outcomes (3)

• DLT

  Incidence of nature of DLTs

  up to 24 months

• AE

  Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0

  up to 24 months

• ECG test evaluated by QTc

  Change QTc from baseline (\> 500 msec)

  up to 24 months

Secondary Outcomes (4)

• Pharmacokinetic (PK) profile

  up to cycle 3 day 1(approximately 9 weeks)

• Anti-tumor activity

  up to 24 months

• Immunogenicity

  up to 24 months

• Exploratory Biomarker

  up to 24 months

Study Arms (1)

GX-I7

EXPERIMENTAL

Determined dose of GX-I7 on Day1 of each cycle

Drug: GX-I7

Interventions

GX-I7 DRUG

GX-I7 25mg/ml/vial

GX-I7

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (3)

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

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

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40490502 DERIVED

MeSH Terms

Interventions

efineptakin alfa

Study Officials

• Joo Hyuk Sohn, MD

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

• Tae Won Kim, MD

  Medical Oncology, Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Myoung-Ah Lee, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: March 27, 2018
• Study Start: March 5, 2018
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

KR (3)