drugset / Trial / NCT03345485
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Non-randomizedSequentialOpen-labelTreatment
Summary
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2022-07-27
- Completion
- 2023-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tinostamustine | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Tinostamustine | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Tinostamustine | Other / unclassified | 100 mg/m2 | Intravenous |