Spots Global Cancer Trial Database for Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
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Trial Identification
Brief Title: Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Official Title: Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Study ID: NCT04262466
Conditions
Study Description
Brief Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.
Detailed Description: The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of IMC-F106C as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies. 2. Phase 2: To assess the efficacy of IMC-F106C in selected advanced solid tumors.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California - San Diego, La Jolla, California, United States
Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California Davis Comprehensive Center, Sacramento, California, United States
University of Colorado, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Houston Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Washington - Fred Hutchinson Cancer Center, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Scientia Clinical Research, Randwick, New South Wales, Australia
Melanoma Institute Australia (MIA) - The Poche Centre, Wollstonecraft, New South Wales, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, , Austria
Universitair Ziekenhuis Brussel, Jette, Brussel, Belgium
CHU de Liege, Liège, Luik, Belgium
Institut Jules Bordet, Bruxelles, , Belgium
UZA, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Hospital Nossa Senhora da Conceicao, Porto Alegre, , Brazil
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CHUM Centre de Recherche, Montréal, Quebec, Canada
Gustave Roussy (Institut de Cancerologie Gustave-Roussy), Villejuif, Val De Marne, France
Universite Claude Bernard Lyon Est, Lyon, Villeurbanne, France
Hopital Saint-Louis - Centre d'Onco-Dermatologie, Paris, , France
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche, Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica, Seriate, Roma, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale, Napoli, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University College of Medicine, Seoul, , Korea, Republic of
University of Ulsan College of Medicine, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, CX, Netherlands
UMC Groningen Comprehensive Cancer Center, Groningen, GZ, Netherlands
Leiden UMC, Leiden, ZA, Netherlands
New Zealand Clinical Research-Auckland, Auckland, , New Zealand
Centrum Medyczne Pratia Poznan - Skorzewo, Skórzewo, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona, Pamplona, Navarra, Spain
NEXT Barcelona, Barcelona, , Spain
Hospital Universitario Vall dHebron, Barcelona, , Spain
Hospital Duran i Reynals, Barcelona, , Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
University Hospital, Basel Switzerland, Basel, , Switzerland
University Hospital of Zurich, Zürich, , Switzerland
Sarah Cannon Research Institute UK, London, City Of London, United Kingdom
University of Oxford, Oxford, Oxfordshire, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
University of Liverpool, Liverpool, , United Kingdom
University College Hospital London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Marsden Hospital, Surrey Quays, , United Kingdom
Contact Details
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