Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Martin Allen-Auerbach (ucla)

Description

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.

Official Title

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

Keywords

GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET, SSTR+, targeted radiotherapy, RayzeBio, Actinium, Ac 225, Dotatate, Everolimus, sunitinib, octreotide, lanreotide, PRRT, alpha emitter, Neoplasms, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, RYZ101

Eligibility

Locations

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RayzeBio, Inc.
ID
NCT05477576
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 288 study participants
Last Updated