Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Recruiting now · Phase 3
Conditions studied: GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET
In brief
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.
Key facts
- Study ID
- NCT05477576
- Run by
- RayzeBio, Inc.
- People needed
- 338
- Starts
- 2022-03-24
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Facility — Barcelona, Spain (enrolling)
- Research Facility — New York, New York, United States (enrolling)
- Research Facility — Vandœuvre-lès-Nancy, France (enrolling)
- Research Facility — Utrecht, Netherlands (enrolling)
- Research Facility — Columbus, Ohio, United States (enrolling)
- Research Facility — Irvine, California, United States (enrolling)
- Research Facility — Seattle, Washington, United States (enrolling)
- Research Facility — Lille, France (enrolling)
- Research Facility — Miami, Florida, United States (enrolling)
- Research Facility — Amsterdam, Netherlands (enrolling)
- Research Facility — Madrid, Spain (enrolling)
- Research Facility — Iowa City, Iowa, United States (enrolling)
- Research Facility — Lexington, Kentucky, United States (enrolling)
- Research Facility — Glen Burnie, Maryland, United States (enrolling)
- Research Facility — Pittsburgh, Pennsylvania, United States (enrolling)
- Research Facility — Salt Lake City, Utah, United States (enrolling)
- Research Facility — Brussels, Belgium (enrolling)
- Research Facility — Clichy, France (enrolling)
- Research Facility — St Louis, Missouri, United States (enrolling)
- Research Facility — Omaha, Nebraska, United States (enrolling)
- Research Facility — Tampa, Florida, United States (enrolling)
- Research Facility — New Haven, Connecticut, United States
- Research Facility — Cleveland, Ohio, United States
- Research Facility — Atlanta, Georgia, United States
- Research Facility — San Francisco, California, United States
Full record on ClinicalTrials.gov
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