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

ClinicalTrials.gov ID: NCT05477576

Public ClinicalTrials.gov record NCT05477576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 2:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05477576
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: RayzeBio, Inc.; Industry
Enrollment: 338 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 23, 2022
Primary completion: Nov 30, 2026
Completion: Nov 30, 2030
Last update posted: Mar 29, 2026

2022 – 2030

United States locations

U.S. sites: 32
U.S. states: 22
U.S. cities: 30

Facility	City	State	ZIP	Site status
Research Facility	Phoenix	Arizona	85054	Active, not recruiting
Research Facility	Duarte	California	91010	Completed
Research Facility	Irvine	California	92663	Recruiting
Research Facility	Los Angeles	California	90095	Active, not recruiting
Research Facility	Palo Alto	California	94305	Active, not recruiting
Research Facility	San Francisco	California	94143	Active, not recruiting
Research Facility	New Haven	Connecticut	06510	Active, not recruiting
Research Facility	Washington D.C.	District of Columbia	20010	Active, not recruiting
Research Facility	Jacksonville	Florida	32224	Active, not recruiting
Research Facility	Miami	Florida	33165	Recruiting
Research Facility	Tampa	Florida	33607	Recruiting
Research Facility	Atlanta	Georgia	30322	Active, not recruiting
Research Facility	Iowa City	Iowa	52242	Recruiting
Research Facility	Lexington	Kentucky	40536	Recruiting
Research Facility	Glen Burnie	Maryland	21061	Recruiting
Research Facility	Boston	Massachusetts	02118	Active, not recruiting
Research Facility	Boston	Massachusetts	02215	Active, not recruiting
Research Facility	Troy	Michigan	48098	Completed
Research Facility	Rochester	Minnesota	55905	Active, not recruiting
Research Facility	St Louis	Missouri	63110	Recruiting
Research Facility	Omaha	Nebraska	68130	Recruiting
Research Facility	New York	New York	10029	Active, not recruiting
Research Facility	New York	New York	10065	Recruiting
Research Facility	Cleveland	Ohio	44106	Active, not recruiting
Research Facility	Columbus	Ohio	43221	Recruiting
Research Facility	Portland	Oregon	97239	Active, not recruiting
Research Facility	Philadelphia	Pennsylvania	19104	Active, not recruiting
Research Facility	Pittsburgh	Pennsylvania	15232	Recruiting
Research Facility	Nashville	Tennessee	37232	Active, not recruiting
Research Facility	Houston	Texas	77030	Active, not recruiting
Research Facility	Salt Lake City	Utah	84112	Recruiting
Research Facility	Seattle	Washington	98109	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05477576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 29, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05477576 live on ClinicalTrials.gov.

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