Spots Global Cancer Trial Database for Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
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Trial Identification
Brief Title: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Official Title: Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy
Study ID: NCT05477576
Study Description
Brief Summary: This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
UCLA Nuclear Medicine, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Stanford University, Palo Alto, California, United States
University of California, San Francisco, San Francisco, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Biogenix Molecular, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Emory University Hospital Midtown, Atlanta, Georgia, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
Advanced Molecular Imaging and Therapy, Glen Burnie, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Profound Research LLC/MHP Radiation Oncology Institute, Troy, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University - St. Louis, Saint Louis, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson, Houston, Texas, United States
Huntsman Cancer Hospital University of Utah, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Institut Jules Bordet, Brussels, , Belgium
Cliniques universitaires Saint-Luc, Brussel, , Belgium
UZ Leuven, Leuven, , Belgium
AZ Delta, Roeselare, , Belgium
Sociedade Beneficente De Senhoras Hospital - Sírio-Libanês Brasilia, Brasília, , Brazil
Instituto D'or de Pesquisa e Ensino, Rio De Janeiro, , Brazil
Instituto Nacional de Cancer, Rio De Janeiro, , Brazil
Fundacao Antonio Prudente - A.C. Camargo Cancer Center, São Paulo, , Brazil
Hospital Israelita Albert Einstein, São Paulo, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio-Libanes, São Paulo, , Brazil
London Health Sciences Centre, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
University Health Network - Princess Margaret Cancer Centre, Toronto, , Canada
CHU Beaujon, APHP.Nord - Université Paris Cité, Clichy, , France
CHRU de Lile, Lille, , France
CHU De Nantes, Nantes, , France
CHRU de Nancy Hôpital de Brabois, Vandoeuvre-Lès-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
UMC Utrecht, Utrecht, , Netherlands
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital HM Universitario Sanchinarro, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Denis Ferreira, MD
Affiliation: RayzeBio Sr. Medical Director
Role: STUDY_DIRECTOR
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