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

NCT03478995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-05-11

No results posted yet for this study

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

Interventions

DRUG

GX-I7

GX-I7 25mg/ml/vial

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

  • Joo Hyuk Sohn, MD · Yonsei University Health System, Severance Hospital

  • Tae Won Kim, MD · Medical Oncology, Asan Medical Center

  • Myoung-Ah Lee, MD · Medical Oncology, Seoul St. Mary's Hospital, of the Catholic University

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2020-03-16
Completion
2020-03-16

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478995 on ClinicalTrials.gov