An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

Phase 1 Terminated 25 enrolled Incyte Corporation

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.

Timeline

Start: 2017-05-25
Primary completion: 2020-06-10
Completion: 2020-06-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Business): “Strategic Business Decision”

paper the study was terminated before establishing an MTD. PMID 36787089 ↗

Publications

Harding JJ, Jungels C, Machiels JP, Smith DC, Walker C, Ji T, Jiang P, Li X, Asatiani E, Van Cutsem E, Abou-Alfa GK. First-in-Human Study of INCB062079, a Fibroblast Growth Factor Receptor 4 Inhibitor, in Patients with Advanced Solid Tumors. Target Oncol. 2023 Mar;18(2):181-193. doi: 10.1007/s11523-023-00948-8. Epub 2023 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	INCB062079	Unknown	10 mg	Oral
Subject	INCB062079	Unknown	15 mg	Oral