First in Human Dose Escalation Study of Vactosertib (TEW-7197) in Subjects With Advanced Stage Solid Tumors

Advanced Stage Solid Tumors Clinical Trial

Official title: First-in-Human Dose-Escalation Study of Vactosertib (TEW-7197) Monotherapy in Subjects With Advanced Stage Solid Tumors

Status Completed

Clinical Trial Summary

The phase I dose escalation study will investigate the safety, tolerability, and pharmacokinetics of the TGF-β pathway inhibitor TEW 7197 in subjects with advanced, refractory solid tumors.

Clinical Trial Description

This is an open-label, multicenter, dose-escalation, phase I study of TEW-7197 in subjects with advanced solid tumors. The study will investigate the safety, tolerability, and pharmacokinetics of TEW-7197, and will define the maximum tolerated dose (MTD) of TEW-7197 using a 3 + 3 design. An expansion phase at the MTD will identify the recommended phase 2 dose, with an emphasis on subjects with melanoma, breast cancer, hepatocellular carcinoma, and prostate cancer. TEW-7197 is an orally bioavailable small molecule that inhibits protein serine/threonine kinase of activin receptor-like kinase 5 (ALK5) and blocks intracellular signaling of TGF-β by inhibiting the phosphorylation of ALK5 substrates. ;

Related Conditions & MeSH terms

• Advanced Stage Solid Tumors

• NCT number: NCT02160106
• Study type: Interventional
• Source: MedPacto, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 29, 2014
• Completion date: August 28, 2018