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

Active:	No
Cancer Type:	Neuroendocrine Tumor Pancreatic Cancer Unknown Primary	NCT ID:	NCT05477576
Trial Phases:	Phase III	Protocol IDs:	RYZ101-301 (primary) NCI-2022-06406
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	RayzeBio, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05477576

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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