Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Start Date
3/24/2022
Completion Date
12/1/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
RYZ101
Everolimus
Sunitinib
Octreotide
Lanreotide
Conditions
Locations
Research Facility
Phoenix, Arizona 85054
United States
Research Facility
Duarte, California 91010
United States
Research Facility
Irvine, California 92663
United States
Research Facility
Los Angeles, California 90095
United States
Research Facility
Palo Alto, California 94305
United States
Research Facility
San Francisco, California 94143
United States
Research Facility
New Haven, Connecticut 06510
United States
Research Facility
Washington D.C., District of Columbia 20010
United States
Research Facility
Jacksonville, Florida 32224
United States
Research Facility
Miami, Florida 33165
United States
Research Facility
Tampa, Florida 33607
United States
Research Facility
Atlanta, Georgia 30322
United States
Research Facility
Iowa City, Iowa 52242
United States
Research Facility
Lexington, Kentucky 40536
United States
Research Facility
Glen Burnie, Maryland 21061
United States
Research Facility
Boston, Massachusetts 02118
United States
Research Facility
Boston, Massachusetts 02215
United States
Research Facility
Troy, Michigan 48098
United States
Research Facility
Rochester, Minnesota 55905
United States
Research Facility
St Louis, Missouri 63110
United States
Research Facility
Omaha, Nebraska 68130
United States
Research Facility
New York, New York 10029
United States
Research Facility
New York, New York 10065
United States
Research Facility
Cleveland, Ohio 44106
United States
Research Facility
Columbus, Ohio 43221
United States
Research Facility
Portland, Oregon 97239
United States
Research Facility
Philadelphia, Pennsylvania 19104
United States
Research Facility
Pittsburgh, Pennsylvania 15232
United States
Research Facility
Nashville, Tennessee 37232
United States
Research Facility
Houston, Texas 77030
United States
Research Facility
Salt Lake City, Utah 84112
United States
Research Facility
Seattle, Washington 98109
United States
Research Facility
Brussels,
Belgium
Research Facility
Leuven,
Belgium
Research Facility
Roeselare,
Belgium
Research Facility
Brasília,
Brazil
Research Facility
Rio de Janeiro,
Brazil
Research Facility
São Paulo,
Brazil
Research Facility
London, Ontario
Canada
Research Facility
Toronto, Ontario M4N 3M5
Canada
Research Facility
Montreal, Quebec
Canada
Research Facility
Clichy,
France
Research Facility
Lille,
France
Research Facility
Montpellier,
France
Research Facility
Nantes,
France
Research Facility
Vandœuvre-lès-Nancy,
France
Research Facility
Villejuif,
France
Research Facility
Amsterdam,
Netherlands
Research Facility
Maastricht,
Netherlands
Research Facility
Utrecht,
Netherlands
Research Facility
Seoul,
South Korea
Research Facility
Barcelona,
Spain
Research Facility
Madrid,
Spain
Research Facility
Zaragoza,
Spain