Last updated on May 2018

Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma

Brief description of study

This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive escalating doses of ADCT-301 every 3 weeks.

In Part 2 of the study, patients will receive a recommended dose(s) of ADCT-301 every 3 weeks.

Detailed Study Description

This is a Phase I, first in human clinical study with ADCT-301 to evaluate the safety and tolerability and pharmacokinetics of ADCT-301 in patients with relapsed/refractory lymphoma.

ADCT-301 is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.

The study will be conducted in 2 parts: In part 1 (dose escalation) up to 80 patients will receive an infusion of ADCT-301 on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

In Part 2 (expansion) up to 60 patients will be assigned to receive the recommended dose(s) of ADCT-301 as determined by a Dose Escalation Steering Committee.

For each patient, the study will include a screening period (up to 28 days), a treatment period, and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall patient tolerability to the study drug and response to treatment. It is anticipated that the entire study (Parts 1 and 2) could last approximately 3 years from first patient treated to last patient completed.

Clinical Study Identifier: NCT02432235

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Steven Horwitz, MD

Memorial Sloan-Kettering Cancer Center
New York, NY United States
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Felipe Samaneigo, MD

The University of Texas/MD Anderson Cancer Center
Houston, TX United States
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Anand Karnad, MD

Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio
San Antonio, TX United States
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Alexander Spira, MD, PhD

Virginia Cancer Specialists, PC
Fairfax, VA United States
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Mehdi Hamadani, MD

Froedtert Hospital/Medical College of Wisconsin
Milwaukee, WI United States
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Paul A Fields, MBchB

Guy's and St. Thomas' Hospital NHS Trust
London, United Kingdom
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Tobias F Menne, MD

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
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Graham P Collins, MBBS

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
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John Radford, MD

The Christie NHS Foundation Trust
Manchester, United Kingdom
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Andrew J Davies, MBBS

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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Paolo F Caimi, MD

University Hospitals Cleveland Medical Center
Cleveland, OH United States
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