NCT05477576

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: RayzeBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GEP-NET
• Gastroenteropancreatic Neuroendocrine Tumor
• Gastroenteropancreatic Neuroendocrine Tumor Disease
• Neuroendocrine Tumors
• Carcinoid
• Carcinoid Tumor
• Pancreatic NET

Interventions

Type	Name	Description
DRUG	RYZ101	RP3D as determined in Phase 1b
DRUG	Everolimus	Everolimus
DRUG	Sunitinib	Sunitinib
DRUG	Octreotide	High-dose octreotide
DRUG	Lanreotide	Lanreotide

Timeline

• Start date: 2022-03-24
• Primary completion: 2026-12-01
• Completion: 2030-12-01
• First posted: 2022-07-28
• Last updated: 2026-03-30

Locations

54 sites across 8 countries: United States, Belgium, Brazil, Canada, France, Netherlands, South Korea, Spain

Regulatory

• FDA-regulated drug study