Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Public ClinicalTrials.gov record NCT03345485. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of EDO-S101, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients With Advanced Solid Tumors. Sub-study to Characterize the Effects of Tinostamustine at a Dose of 60mg/m2 Administered During a 60 Minutes Infusion on Cardiac Repolarization, in Patients With Advanced Solid Tumors. Sub-study to Characterize the Effects of Tinostamustine at a Dose of 80mg/m2 Administered During a 80 Minutes Infusion on Cardiac Repolarization, in Patients With Advanced Solid Tumors.
Study identification
- NCT ID
- NCT03345485
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Mundipharma Research Limited
- Industry
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Interventions
- Tinostamustine 100mg/m2 over 30min Drug
- Tinostamustine 100mg/m2 over 60min Drug
- Tinostamustine 60mg/m2 over 30min Drug
- Tinostamustine 60mg/m2 over 60min Drug
- Tinostamustine 80mg/m2 over 30min Drug
- Tinostamustine 80mg/m2 over 60min Drug
- Tinostamustine 80mg/m2 over 80min Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2017
- Primary completion
- Jul 26, 2022
- Completion
- Mar 28, 2023
- Last update posted
- Oct 20, 2024
2017 – 2023
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| New York University | New York | New York | 10016 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75251 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03345485, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2024 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03345485 live on ClinicalTrials.gov.