12
Participants
Start Date
January 1, 2020
Primary Completion Date
August 2, 2021
Study Completion Date
September 29, 2021
GTB-3550 TriKE® Phase I
"The 1st two patients will be assigned Dose Level 1. The study statistician will assign each new cohort of 2 patients to the most appropriate dose level based on updated toxicity probabilities.~* Dose Level 1 - 5 μg/kg/day~* Dose Level 2 - 10 μg/kg/day~* Dose Level 3 - 25 μg/kg/day~* Dose Level 4 - 50 μg/kg/day~* Dose Level 5 - 100 μg/kg/day~* Dose Level 6 - 150 μg/kg/day~* Dose Level 7 - 200 μg/kg/day"
GTB-3550 TriKE® Phase II
Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.
University of Wisconsin Clinical Science Center, Madison
Masonic Cancer Center, University of Minnesota, Minneapolis
Lead Sponsor
GT Biopharma, Inc.
INDUSTRY