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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Solid Tumors
  • Neoplasms

NCT number NCT03478995
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 5, 2018
Completion date March 16, 2020

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