Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.

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.

Conditions

• Small Cell Lung Cancer
• Soft Tissue Sarcoma
• Triple-negative Breast Cancer
• Ovarian Cancer
• Endometrial Cancer

Interventions

DRUG

Tinostamustine 60mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 60mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 100mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 100mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 60mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 60mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 100mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 100mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 80min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 80 minutes on Days (D) 1 and 15 of each 28-day cycle.

Sponsors & Collaborators

• Mundipharma Research Limited

  lead INDUSTRY

Principal Investigators

• Shivaani Kummar, MD · Oregon Health and Science University

• Ana Oaknin, MD · Head of Gynaecologic Cancer Program, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-08

Primary Completion

2022-07-27

Completion

2023-03-29

FDA Drug

Yes

Countries

• United States
• Canada
• Italy
• Netherlands
• Spain

Study Locations