Spots Global Cancer Trial Database for Study of DF1001 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of DF1001 in Patients With Advanced Solid Tumors
Official Title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Study ID: NCT04143711
Conditions
Study Description
Brief Summary: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Irvine Medical Center, Irvine, California, United States
University of Southern California, Los Angeles, California, United States
Sharp Healthcare, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
University of Kansas Medical Center Research Institute, Inc., Westwood, Kansas, United States
Louisiana State University, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Multicare Health System Tacoma General Hospital, Tacoma, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Centre Hospitalier de l'Ardenne, Arlon, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Domaine Universitaire du Sart Tilman; CHU de Liege, Liège, , Belgium
Rigshospitalet, Copenhagen, Hovedstaden, Denmark
Herlev og Gentofte Hospital, Herlev, , Denmark
Groupe Hospitalier Saint Andre, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Institut Curie, Paris, , France
ICO - Site Rene Gauducheau, Saint Herblain, , France
Institut Claudius Regaud, Toulouse Cedex 09, , France
Amsterdam University Medical Center, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Maasticht University Medical Center, Maastricht, , Netherlands
Radboud University Nijmegen, Nijmegen, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Contact Details
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