Spots Global Cancer Trial Database for Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors
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Trial Identification
Brief Title: Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors
Official Title: A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
Study ID: NCT04901806
Interventions
Study Description
Brief Summary: This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.
Detailed Description: This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors. Phase 1 will also include subjects with NTRK-amplified advanced or metastatic solid tumors or refractory EWSR1-WT1-fusion-positive desmoplastic small round cell tumors (DSRCTs). Phase 1 is the dose-escalation portion of the study in which the evaluation of safety and tolerability and establishing the RP2D are primary objectives. Once the RP2D has been established, two expansion cohorts will open to accrual, a Non-Brain Primary Tumor cohort and a Primary Brian Tumor cohort. Although this was intended to be a Phase 1/2 trial, the trial was terminated without proceeding to Phase 2.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John Wayne Cancer Institute at St. Johns Health Center, Santa Monica, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists, Lake Mary, Florida, United States
Sylvester Comprehensive Cancer Center (University of Miami), Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Westchester Medical Center, Hawthorne, New York, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Rigshospitalet, University Hospital of Copenhagen, Copenhagen, , Denmark
Institut Bergonie, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Hopital Europeen Georges Pompidou, Paris, , France
CHU Poitiers - Hopital la Miletrie, Poitiers, , France
Institut Gustave Roussy, Villejuif, , France
Dr. Senckenberg Institute of Neurooncology, Frankfurt am Main, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Marienhospital Herne, Herne, , Germany
Queen Mary Hospital, Pok Fu Lam, , Hong Kong
Prince of Wales Hospital, Sha Tin, , Hong Kong
Azienda Ospedaliero Universitaria delle Marche, Ancona, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale Tumori, Milano, , Italy
IRCCS (IEO) Istituto Europeo di Oncologia, Milano, , Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Seoul National University Bundang Hosptial, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent Hosptial, Suwon-si, Gyeonggi-do, Korea, Republic of
Severance Hosptial, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Soul St. Mary's Hosptial, Seoul, , Korea, Republic of
National Cancer Centre Singapore, Singapore, , Singapore
Hospital Universitari Vall d Hebron, Barcelona, , Spain
ICO l Hospitalet, L'Hospitalet De Llobregat, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital General de Catalunya, Sant Cugat Del Vallès, , Spain
The Christie, Manchester, , United Kingdom
Royal Marsden Hospital Institute Cancer Research, Sutton, , United Kingdom
Contact Details
Name: Chief Medical Officer
Affiliation: Pyramid Biosciences
Role: STUDY_DIRECTOR
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