NCT02160106

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: MedPacto, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Stage Solid Tumors

Interventions

Type	Name	Description
DRUG	TEW-7197	Single daily doses by oral administration on Days 1, 2, 3, 4, 5, Days 8, 9, 10, 11, 12, Days 15, 16, 17, 18, 19 and Days 22, 23, 24, 25, 26 of each 28 day cycle. Starting dose is 30 mg, with escalation to 60 mg, and subsequent dose escalation using a modified Fibonacci algorithm.

Timeline

• Start date: 2014-07-29
• Primary completion: 2018-07-31
• Completion: 2018-08-28
• First posted: 2014-06-10
• Last updated: 2019-05-09

Locations

3 sites across 1 country: United States