Study of GNS561 in Patients With Liver Cancer

Phase 1/2 Terminated 50 enrolled Genoscience Pharma

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a first in human, open-label dose escalation study to investigate the safety, tolerability and pharmacokinetics of GNS561 in patients Primary and Secondary liver cancer

Timeline

Start: 2018-04-04
Primary completion: 2021-01-15
Completion: 2022-04-25

Outcome

Outcome not reported

Stopped: “only phase 1b was completed and the phase 2 will be an another study, finally”

Publications

Harding JJ, Awada A, Roth G, Decaens T, Merle P, Kotecki N, Dreyer C, Ansaldi C, Rachid M, Mezouar S, Menut A, Bestion EN, Paradis V, Halfon P, Abou-Alfa GK, Raymond E. First-In-Human Effects of PPT1 Inhibition Using the Oral Treatment with GNS561/Ezurpimtrostat in Patients with Primary and Secondary Liver Cancers. Liver Cancer. 2022 Feb 15;11(3):268-277. doi: 10.1159/000522418. eCollection 2022 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezurpimtrostat	Small molecule	50 mg	Oral
Subject	Ezurpimtrostat	Small molecule	200 mg	Oral
Subject	Ezurpimtrostat	Small molecule	300 mg	Oral
Subject	Ezurpimtrostat	Small molecule	400 mg	Oral