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Study identifier: NCT05477576 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Condition: GEP-NET · Gastroenteropancreatic Neuroendocrine Tumor · Gastroenteropancreatic Neuroendocrine Tumor Disease  ·  Sponsor: RayzeBio, Inc.

PhasePhase 3
Planned participants338
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

RayzeBio Clinical Trials  ·  +1 619 657 0057  ·  clinicaltrials@rayzebio.com

Always discuss trial participation with your own doctor first.

Locations (54)

Research FacilityPhoenix, Arizona, United StatesActive Not Recruiting
Research FacilityDuarte, California, United StatesCompleted
Research FacilityIrvine, California, United StatesRecruiting
Research FacilityLos Angeles, California, United StatesActive Not Recruiting
Research FacilityPalo Alto, California, United StatesActive Not Recruiting
Research FacilitySan Francisco, California, United StatesActive Not Recruiting
Research FacilityNew Haven, Connecticut, United StatesActive Not Recruiting
Research FacilityWashington D.C., District of Columbia, United StatesActive Not Recruiting
Research FacilityJacksonville, Florida, United StatesActive Not Recruiting
Research FacilityMiami, Florida, United StatesRecruiting
Research FacilityTampa, Florida, United StatesRecruiting
Research FacilityAtlanta, Georgia, United StatesActive Not Recruiting

+ 42 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05477576