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 Oct 22, 2026, 8:52 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: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: RayzeBio, Inc.; Industry
Enrollment: 343 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 24, 2022 (Actual)
Primary completion: Dec 2026 (Estimated)
Completion: Dec 2030 (Estimated)
Last update posted: Oct 5, 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	—
Research Facility	Duarte	California	91010	—
Research Facility	Irvine	California	92663	—
Research Facility	Los Angeles	California	90095	—
Research Facility	Palo Alto	California	94305	—
Research Facility	San Francisco	California	94143	—
Research Facility	New Haven	Connecticut	06510	—
Research Facility	Washington D.C.	District of Columbia	20010	—
Research Facility	Jacksonville	Florida	32224	—
Research Facility	Miami	Florida	33165	—
Research Facility	Tampa	Florida	33607	—
Research Facility	Atlanta	Georgia	30322	—
Research Facility	Iowa City	Iowa	52242	—
Research Facility	Lexington	Kentucky	40536	—
Research Facility	Glen Burnie	Maryland	21061	—
Research Facility	Boston	Massachusetts	02118	—
Research Facility	Boston	Massachusetts	02215	—
Research Facility	Troy	Michigan	48098	—
Research Facility	Rochester	Minnesota	55905	—
Research Facility	St Louis	Missouri	63110	—
Research Facility	Omaha	Nebraska	68130	—
Research Facility	New York	New York	10029	—
Research Facility	New York	New York	10065	—
Research Facility	Cleveland	Ohio	44106	—
Research Facility	Columbus	Ohio	43221	—
Research Facility	Portland	Oregon	97239	—
Research Facility	Philadelphia	Pennsylvania	19104	—
Research Facility	Pittsburgh	Pennsylvania	15232	—
Research Facility	Nashville	Tennessee	37232	—
Research Facility	Houston	Texas	77030	—
Research Facility	Salt Lake City	Utah	84112	—
Research Facility	Seattle	Washington	98109	—

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 Oct 5, 2026 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05477576 live on ClinicalTrials.gov.

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