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Clinical trial

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.

NCT03345485 is registered in ClinicalTrials.gov with Mundipharma Research Limited as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

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.
Lead sponsor
Mundipharma Research Limited
Phase
Phase 1/2
Overall status
Completed
Start date
November 8, 2017
Completion date
March 29, 2023
Enrollment
71 (actual)
Sites
13

Conditions

As the registry lists them; a condition with its own page is linked.

endometrial cancer, ovarian cancer, small cell lung cancer, soft tissue sarcoma, triple-negative breast cancer