NCT03429218

First-in-human Study of Oral TP-0184 in Patients With Advanced Solid Tumors

A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0184 Administered Once Weekly for 4 Weeks to Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TP-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active serine/threonine receptor kinase due to activating mutations or upregulated upstream signaling pathways. 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-0184 administered once weekly for 4 weeks 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-0184 administered once weekly for 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: * To establish the pharmacokinetics of orally administered TP-0184 * To observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment * To study the pharmacodynamics of TP-0184 therapy * To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0184

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TP-0184	Oral dose once weekly for 4 weeks

Timeline

• Start date: 2018-07-10
• Primary completion: 2021-03-08
• Completion: 2021-03-08
• First posted: 2018-02-12
• Last updated: 2023-11-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study