Last updated on April 2018

Study of EDO-S101 A First-in-Class Alkylating HDACi Fusion Molecule in Relapsed/Refractory Hematologic Malignancies

Brief description of study

This study evaluates the efficacy, safety and pharmacokinetics of EDO-S101 in patients with relapsed/refractory hematologic malignancies. All patients will receive EDO-S101.

Detailed Study Description

EDO-S101 is a new chemical entity, a first-in-class fusion molecule of an alkylator, bendamustine and a histone-deacetylase inhibitor (HDACi), vorinostat. It is anticipated that EDO-S101 may have activity in various hematological malignancies and solid tumors. This phase 1 study will enroll patients with various hematological malignancies.

The study consists of 2 stages:

  • Stage 1: Dose Escalation to determine Maximum Tolerated Dose (MTD) at the optimal infusion time and the pharmacokinetic (PK) profiles; is expected to enroll between 21 and 48 patients
  • Stage 2: Expansion in four Cohorts, in which approximately 12 patients will be enrolled per cohort, for a total of 48 patients.

In Stage 1, EDO-S101 doses will be escalated following the standard 3+3 design. The decision to escalate to the next dose level will occur after all cohort patients have completed 3 weeks (21 days) of observation and have been evaluated for safety and toxicity.The starting dose is a 1 hour infusion of 20 mg/m2, and the maximum dose level is 150 mg/m2. Reduced infusion times of 45 minutes and 30 minutes will also be assessed once the maximum tolerated dose at a 1-hour infusion is determined.

In Stage 2, four cohorts of patients (with relapsed/refractory multiple myeloma or Waldenstrm Macroglobulinemia; relapsed/refractory Hodgkin's lymphoma; relapsed/refractory peripheral T-cell lymphoma, or relapsed/refractory non-Hodgkin's lymphoma [except chronic lymphocytic and cutaneous T-cell lymphoma] who have been treated or are refractory to bendamustine); and relapsed/refractory peripheral T-cell lymphoma (PTCL) and T-cell Prolymphocytic leukemia (T-PLL) will be enrolled and treated at the recommended Phase 2 dose (RP2D) based on results of Stage 1. Treatment will occur every 21 days. Patients in each stage of the study are expected to receive a median of four 3-week Cycles of therapy, and the maximum number of treatment Cycles allowed is 6.

Clinical Study Identifier: NCT02576496

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Leif Bergsagel, MD

Mayo Clinic
Phoenix, AZ United States
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Han W. Tun, MD

Mayo Clinic Cancer Center
Jacksonville, FL United States
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Hartmut Goldschmidt, MD

University Hospital of Heidelberg - medical department V
Heidelberg, Germany
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Luigi Zinzani, MD

Institute of Hematology "L. A. Ser gnoli", University of Bologna
Bologna, Italy
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Antonio Pinto, MD

National Cancer Institute, Fondazione 'G. Pascale'
Naples, Italy
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Christoph Driessen, MD

Kantonsspital St.Gallen
St.Gallen, Switzerland
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Owen A O'Connor, MD,PhD

Columbia University Medical Center
New York, NY United States
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Von Treskow, MD

University Hospital of Cologne - Department I of Internal Medicine
Köln, Germany
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