A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Status: Completed
Location: See all (118) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures

• In Japan, if a subject is < 20 years, the written informed consent from his/her parent or guardian will be required in addition to the subject's written consent

• Male or female subjects aged greater than or equal to (>=) 18 years

• Life expectancy >= 12 weeks as judged by the Investigator

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry

• Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Adequate hematological, hepatic and renal function as defined in the protocol

• Effective contraception for both male and female subjects if the risk of conception exists

• Other protocol-defined inclusion criteria could apply.

Locations
United States
Arizona
Arizona Clinical Research Center
Tucson
California
Pacific Oncology Associates
Escondido
University of California Davis Health System
Sacramento
California Pacific Medical Center
San Francisco
Innovative Clinical Research Institute
Whittier
Colorado
Rocky Mountain Cancer Centers, LLP
Denver
Connecticut
Eastern Connecticut Hematology/Oncology Assoc.
Norwich
Florida
Sylvester Cancer Center
Miami
Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie
Georgia
University Cancer & Blood Center, LLC
Athens
Southeastern Regional Medical Center
Newnan
Louisiana
Metairie Oncologists, LLC
Metairie
Massachusetts
Dana Farber Cancer Institute
Boston
Maryland
National Cancer Institute
Bethesda
Michigan
Henry Ford Health System
Detroit
Michigan State University
Lansing
Missouri
Washington University
Saint Louis
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
Ohio
UC Health Clinical Trials Office
Cincinnati
Case Comprehensive Cancer Center
Cleveland
Pennsylvania
Penn State University Milton S. Hershey Medical Center
Hershey
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Greenville Hospital System University Medical Center (ITOR)
Greenville
Tennessee
Tennessee Cancer Specialists
Knoxville
Texas
Texas Oncology, P.A. - Austin
Austin
Mary Crowley Cancer Research Centers
Dallas
Texas Oncology, P.A. - Fort Worth
Fort Worth
Oncology Consultants, P.A.
Houston
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
Houston
South Texas Accelerated Research Therapeutics, LLC
San Antonio
Texas Oncology, P.A. - Tyler
Tyler
Virginia
Virginia Cancer Specialists, PC
Fairfax
Virginia Oncology Associates - Hampton
Norfolk
Washington
Compass Oncology
Vancouver
Other Locations
Australia
Blacktown Hospital
Blacktown
Peter MacCallum Cancer Centre-East Melbourne
East Melbourne
Gallipoli Medical Research Foundation Ltd
Greenslopes
St George Hospital
Kogarah
Liverpool Hospital
Liverpool
Cabrini Hospital Malvern
Malvern
Fiona Stanley Hospital
Murdoch
Linear Clinical Research Limited
Nedlands
Port Macquarie Base Hospital
Port Macquarie
Tasman Oncology Research Ltd
Southport
Royal North Shore Hospital
St Leonards
Calvary Mater Newcastle
Waratah
Border Medical Oncology Research Unit
Wodonga
The Queen Elizabeth Hospital
Woodville South
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles
Institut Jules Bordet
Bruxelles
Grand Hôpital de Charleroi
Charleroi
UZ Antwerpen
Edegem
Universitair Ziekenhuis Gent
Gent
Centre Hospitalier de l'Ardenne
Libramont
C. H. U. Sart Tilman
Liège
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk
Canada
Cross Cancer Institute
Edmonton
France
CHU Bordeaux - Hôpital Saint André
Bordeaux Cedex
Hôpital Henri Mondor
Créteil Cedex
Centre Georges François Leclerc
Dijon Cedex
CHU de Grenoble - Hôpital Nord
Grenoble Cedex 9
Centre Oscar Lambret
Lille Cedex
Centre Léon Bérard
Lyon
Centre Hospitalier de la Croix Rousse
Lyon Cedex 04
Hôpital de la Timone#
Marseille Cedex 5
Institut Régional du Cancer de Montpellier
Montpellier
Centre Antoine Lacassagne
Nice Cedex 02
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Paris Cedex 05
Hôpital Saint-Louis
Paris Cedex 10
Groupe Hospitalier Pitie-Salpetriere
Paris Cedex 12
ICO - Site René Gauducheau
Saint Herblain
Centre Paul Strauss
Strasbourg Cedex
Institut Claudius Regaud-Oncopole
Toulouse Cedex 09
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
Medizinische Hochschule Hannover
Hannover
Cellex Koeln
Koeln
Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano
IEO Istituto Europeo di Oncologia
Milano
Ospedale San Raffaele
Milano
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli
Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliero Universitaria Pisana
Pisa
Policlinico Universitario Agostino Gemelli
Roma
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
Japan
National Cancer Center Hospital East
Kashiwa-shi
Kindai University Hospital
Osakasayama-shi
Republic of Korea
Pusan National University Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Spain
Hospital Infanta Cristina
Badajoz
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Centro Integral Oncologico Clara Campal
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Clinico San Carlos
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Virgen del Rocio
Sevilla
Hospital Universitario Virgen Macarena
Sevilla
Hospital Clinico Universitario de Valencia
Valencia
Hospital Universitari i Politecnic La Fe
Valencia
Taiwan
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
United Kingdom
Queen Elizabeth Hospital
Birmingham
Beatson West of Scotland Cancer Centre
Glasgow
Guy's Hospital
London
University College London Hospitals
London
The Christie
Manchester
Northern Centre for Cancer Care
Newcastle Upon Tyne
Southampton General Hospital
Southampton
Time Frame
Start Date: August 31, 2015
Completion Date: May 23, 2022
Participants
Target number of participants: 600
Treatments
Experimental: MSB0011359C (M7824)
Authors
Juan Vidal Oscar, Wang Ding, Flor Oncala Maria Jose, Agajanian Richy, Loannis Karydis, Mark Wong, Osama Rahma, Dennis Slater, Arkadiusz Dudek, Ari Baron, Jennifer Eads, Ji Yeon Baek, Karen Kelly, Jee Hyun Kim, Michael Lee, Christian Rolfo, Paul Conkling, John Nemunaitis, Glen Weiss, Howard Safran, Sharon Wilks, Lynn Feun, Fadi Braiteh, Oana Danciu, Ahmad Awada, Victoria Atkinson, Patricia Thompson, Luis Paz-Ares Rodriguez, Benjamin Tan, Ralph Boccia, Alexander Spira, Bruce Porterfield, Jonathan Moreira, Kyriakos Papadopoulos, Donald Richards, Randeep Sangha, Rodolfo Bordoni, John Morris, Aung Naing, Russell DeVore, Michael Wertheim, Jayne Gurtler, Marwan Fakih, Borys Hrinczenko, Stephen Williamson, Edward McClay, Nelson Yee, Gary Richardson, James Gulley, Carolyn Britten, Allen Cohn, Stephen Richey, Petros Nikolinakos, Donald Harvey, Nicolas Penel, Nicolas Isambert, Fabrice Barlesi, Helmuth Schmidt, Stephen Welch, Sebastian Ochsenreither, Christos Chouaid, Cornelius Waller, Christopher Steer, Christian Borel, Olivier Rosmorduc, Pascaline Boudou-Rouquette, Martin Wermke, Alain Ravaud, Philippe Cassier, Luis Teixeira, Thomas Wehler, Carole Gourmelon, Tjoung-Won Park-Simon, Diego Tosi, Martin Forster, Esma Saada-Bouzid, Emanuela Romano, Antoine Adenis, Joerg Trojan, Yuk Ting Ma, Marie Robert, Ruey-Kuen Hsieh, Manuel Modiano, Enriqueta Felip Font, Salvatore Siena, Jean-Luc Canon, Alfredo Falcone, Stefania Salvagni, Carlo Barone, Edgardo Santos, Marika Rasschaert, Masafumi Ikeda, Paul de Souza, Nick Pavlakis, William Edenfield, Thomas Decaens, Hendrik-Tobias Arkenau, Dong-Wan Kim, Tarek Meniawy, Javier Garcia Corbacho, Luca Gianni, Shahneen Sandhu, Jason Melear, George Au-Yeung, Paolo Ascierto, Jean-Pierre Delord, Craig Gedye, Chia-Chi Lin, Lisa Horvath, Minal Barve, Andrew Hill, Jean-Pascal Machiels, Andres Manuel Cervantes Ruiperez, David Smith, Chee Lee, Helene Regnault, Emiliano Calvo Aller, Chin-Chou Wang, Ki Hyeong Lee, Jeong Heo, Debashis Sarker, Byoung Chul Cho, Matthew Krebs, Armando Santoro, Masatoshi Kudo, Sylvie Rottey, Massimo Di Nicola, Giuseppe Curigliano, Peter Schmid, Her-Shyong Shiah, Konstantin Dragnev, Philippe Merle, Ho Yeong Lim, Guy Jerusalem, David Vicente Baz, Javier Sastre Valera, Jesus Corral Jaime, Enrique Grande Pulido, Massimo Aglietta, Rachel Roberts-Thomson, Baek-Yeol Ryoo, Paolo Pedrazzoli, Stephen Begbie, Jeff Evans, Frédéric Forget, Dae Ho Lee, Julio Peguero, Ruth Plummer, Michele Maio, Miguel Martin Jimenez, Juan Ignacio Delgado Mingorance, David Lorente Estelles, Federico Longo Munoz, Bruno Daniele, Adnan Khattak, Luc Dirix
Sponsors
Leads: EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov

Similar Clinical Trials