Locally Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
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
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
;
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