Spots Global Cancer Trial Database for Study of TP-3654 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Study of TP-3654 in Patients With Advanced Solid Tumors

Official Title: A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients With Advanced Solid Tumors

Study ID: NCT03715504

Conditions

Advanced Solid Tumors

Interventions

TP-3654

Study Description

Brief Summary: TP-3654 is an oral PIM inhibitor. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors.

Detailed Description: Primary Objective: • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors. Secondary Objectives: * To establish the pharmacokinetic (PK) profile of orally administered TP-3654 * To observe patients for any evidence of antitumor activity of TP-3654 by objective radiographic assessment * To study the pharmacodynamic effects of TP-3654 therapy * To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-3654