Study of ASTX029 in Subjects With Advanced Solid Tumors

NCT03520075 ↗

Phase 1/2 Completed 192 enrolled Taiho Oncology, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-05-07
Primary completion: 2024-08-01
Completion: 2025-03-03

Publications

Munck JM, Berdini V, Bevan L, Brothwood JL, Castro J, Courtin A, East C, Ferraldeschi R, Heightman TD, Hindley CJ, Kucia-Tran J, Lyons JF, Martins V, Muench S, Murray CW, Norton D, O'Reilly M, Reader M, Rees DC, Rich SJ, Richardson CJ, Shah AD, Stanczuk L, Thompson NT, Wilsher NE, Woolford AJ, Wallis NG. ASTX029, a Novel Dual-mechanism ERK Inhibitor, Modulates Both the Phosphorylation and Catalytic Activity of ERK. Mol Cancer Ther. 2021 Oct;20(10):1757-1768. doi: 10.1158/1535-7163.MCT-20-0909. Epub 2021 Jul 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BEROTERKIB ANHYDROUS	Small molecule	10 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	20 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	40 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	60 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	80 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	120 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	200 mg	Oral
Subject	BEROTERKIB ANHYDROUS	Small molecule	280 mg	Oral

Study of ASTX029 in Subjects With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications