Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

Phase 1 Completed 106 enrolled Mundipharma Research Limited

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

Timeline

Start: 2016-04-14
Primary completion: 2023-05-30
Completion: 2023-11-21

Publications

Sureda A, Pinto A, Ghesquieres H, Morschhauser F, Tournilhac O, Mutsaers P, Zijlstra JM, De Filippi R, Hilgier K, Manamley N, Janik T, Zinzani PL. Safety and Efficacy of Tinostamustine in a Subpopulation of Patients With Relapsed/Refractory Hodgkin Lymphoma From a Phase I Trial. Hematol Oncol. 2025 Jan;43(1):e70000. doi: 10.1002/hon.70000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tinostamustine	Other / unclassified	20 mg/m2	Intravenous
Subject	Tinostamustine	Other / unclassified	40 mg/m2	Intravenous
Subject	Tinostamustine	Other / unclassified	60 mg/m2	Intravenous
Subject	Tinostamustine	Other / unclassified	80 mg/m2	Intravenous
Subject	Tinostamustine	Other / unclassified	100 mg/m2	Intravenous
Subject	Tinostamustine	Other / unclassified	120 mg/m2	Intravenous

Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

Summary

Timeline

Publications

Drugs

Indications