Mundipharma EDO GmbH has begun a research study of an investigational drug called Tinostamustine. This is being developed for the treatment of hematologic malignancies (cancers in the blood) and solid tumors (cancers elsewhere in the body).

This study is conducted as a phase 1/2 clinical trial. The main purpose of this study is to assess the safety and tolerability of Tinostamustine as conditioning before ASCT in the Phase 1 study and the safety, tolerability and efficacy in the Phase 2 study.

A Phase 1 part of the study will determine the highest dose that can be given without causing significant safety concerns and the recommended dose for the second phase of the study. The recommended dose from this Phase 1 study will be given to other patients in Phase 2 part of the study.

This study drug, Tinostamustine, has been tested in animals. Human experiences are limited to the patients treated in two ongoing clinical studies in patients who have either hematologic and solid tumor cancers.

This study tests different doses of the drug to see which dose is tolerated better in people with multiple myeloma. There will be about 9 to 12 people taking part in the Phase 1 study. There will be about 31 to 71 people taking part in the Phase 2 study.

This study is designed as an open label trial. This means that patients will be enrolled on a sequential basis (one after another), and each patient will know exactly how much of the investigational drug will be administered.