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

Trial ID or NCT#

NCT05477576

Status

recruiting iconRECRUITING

Purpose

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

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Benjamin Lewis Franc
Benjamin Lewis Franc
Radiologist
Clinical Professor, Radiology - Rad/Nuclear Medicine
Carina Mari Aparici
Carina Mari Aparici
Radiologist
Clinical Professor, Radiology - Rad/Nuclear Medicine

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Contact

David Marcellus
650-723-4547