Determined dose of GX-I7 on Day1 of each cycle

GX-I7

Joo Hyuk Sohn, MD

Tae Won Kim, MD

Myoung-Ah Lee, MD

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.

* 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

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

A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors

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

Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)

Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator

Incidence of anti-drug antibodies (ADAs) during the study

Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors	NCT03478995	Locally Advance...	GX-I7	19 Years -	Genexine, Inc.
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors	NCT03478995	Locally Advance...	GX-I7	19 Years -	Genexine, Inc.

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Spots Global Cancer Trial Database for phase1b

Every month we try and update this database with for phase1b cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for phase1b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.