NCT03520075

Study of ASTX029 in Subjects With Advanced Solid Tumors

A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced solid malignancies who are not candidates for approved or available therapies.

Detailed description

ASTX029 is a synthetic small molecule inhibitor of extracellular signal-regulated kinases (ERKs) 1/2. ASTX029 has not been previously evaluated in human participants. The Phase 1 portion of this study will assess safety and determine the maximum tolerated dose, the recommended Phase 2 dose (RP2D), and the recommended dosing regimen of ASTX029 administered orally. The Phase 2 portion will assess preliminary clinical activity in tumors characterized by gene aberrations in the mitogen-activated protein kinase (MAPK) signal pathway that may confer sensitivity to ASTX029.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	ASTX029	PiB
DRUG	ASTX029	Tablet

Timeline

• Start date: 2018-05-07
• Primary completion: 2024-08-01
• Completion: 2025-03-03
• First posted: 2018-05-09
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

31 sites across 4 countries: United States, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study