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A Phase 1/1b, First-In-Human, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, And Pharmacodynamic Study Of Oral TP-1454 Alone And In Combination With Ipilimumab And Nivolumab

Protocol No
TOLERO-TP-1454-101
Principal Investigator
Ariel Nelson
Phase
I
Summary
During Phase 1 of the study (TP-1454 Dose Escalation), patients are enrolled in groups of 3 to 6 at increasing dose levels of TP-1454 until side effects are seen that mean the doses should not be increased any further. The dose level you receive will depend on how many dose levels have been tested so far in this study and how well it was tolerated by other patients before you enter the study. During Phase 1b of the study (TP-1454 in Combination with ipilimumab and nivolumab Dose Escalation), patients are also enrolled in groups of 3 to 6 at increasing dose levels of TP-1454 until side effects are seen that mean the doses should not be increased any further. The dose level you receive will depend on how many dose levels have been tested in this study and how well it was tolerated by other patients before you enter the study. During the Expansion part of Phase 1b, patients will receive TP-1454 at the highest dose found to be safe and well tolerated when combined with ipilimumab and nivolumab. You may also be given standard supporting treatment that is normally given to patients receiving ipilimumab and nivolumab
Description
The primary purpose of this research study is to determine the preliminary safety of TP-1454 alone, or TP-1454 in combination with ipilimumab and nivolumab, at different doses to find out what effects, if any, it has on people with solid tumors. This study will also gain information about the pharmacokinetics or PK (the process by which a drug is absorbed, distributed, metabolized and eventually eliminated by the body) and pharmacodynamic (PD) biomarkers (which are used to examine the drug effect on the body and/or the tumor).

Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL