A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors

Protocol No
TOLERO-TP-0903-101
Principal Investigator
Jonathan Thompson
Phase
I
Summary
TP-0903 is being developed as a novel therapeutic for the potential treatment of a variety of cancer indications including solid tumors. TP-0903 is in capsule form and will be taken by mouth daily for 21 days followed by 7 days off.
Description
The primary purpose of this study is to evaluate the safety of TP-0903 at different doses to find out what effects, if any, it has on people. 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 at a tumor site
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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