NCT03715504

Study of TP-3654 in Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TP-3654	oral PIM inhibitor

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-03-30
• Completion: 2021-07-08
• First posted: 2018-10-23
• Last updated: 2023-11-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study