drugset / Trial / NCT01337505

Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

NCT01337505

Phase 1 Completed 24 enrolled ImmunityBio, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.

Timeline

Start
2011-04
Primary completion
2012-09
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aldoxorubicin Small molecule 230 mg/m2 Intravenous
Subject Aldoxorubicin Small molecule 350 mg/m2 Intravenous
Subject Aldoxorubicin Small molecule 450 mg/m2 Intravenous

Indications