Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Completed · Phase 1/Phase 2
Conditions studied: Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer, Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT03345485
- Run by
- Mundipharma Research Limited
- People needed
- 71
- Starts
- 2017-11-08
- Expected to finish
- 2023-03-29
- Last updated by the study team
- 2024-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Stanford University Medical Center — Palo Alto, California, United States
- University of Michigan — Ann Arbor, Michigan, United States
- New York University — New York, New York, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- Juravinski Cancer Centre — Hamilton, Ontario, on, Canada
- McGill University — Montreal, Quebec, Canada
- BC Cancer-Vancouver — Vancouver, Vancouver, BC, Canada
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
- Istituto Europeo di Oncologia — Milan, Italy
- Erasmus MC Kanker Instituut — Rotterdam, Netherlands
- Hospital Universitario La Paz — Madrid, Fuencarral-El Pardo, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Horta-Guinardó, Spain
Full record on ClinicalTrials.gov
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