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RECRUITING Phase 3

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

NCT05477576 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Everolimus
  • DRUG Sunitinib
  • DRUG Lanreotide
  • DRUG RYZ101
  • DRUG Octreotide

Study Locations (20)

California

  • Research Facility — Duarte
  • Research Facility — Irvine
  • Research Facility — Los Angeles
  • Research Facility — Palo Alto
  • Research Facility — San Francisco

Florida

  • Research Facility — Jacksonville
  • Research Facility — Miami
  • Research Facility — Tampa

Massachusetts

  • Research Facility — Boston
  • Research Facility — Boston

Arizona

  • Research Facility — Phoenix

Connecticut

  • Research Facility — New Haven

District of Columbia

  • Research Facility — Washington D.C.

Georgia

  • Research Facility — Atlanta

Iowa

  • Research Facility — Iowa City

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2022-03-24
Est. Completion 2028-07
Phase Phase 3

Sponsor

RayzeBio

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05477576

The ClinicalTrials.gov registry entry for NCT05477576 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RayzeBio, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 5 interventions — of which Everolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05477576 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05477576 about?

NCT05477576 is a clinical study titled "Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy". 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, ...

What is the current status of trial NCT05477576?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2022-03-24. Estimated completion is 2028-07.

What conditions does trial NCT05477576 study?

This clinical trial studies the following conditions: Neuroendocrine Tumors, Carcinoid Tumor, Gastroenteropancreatic Neuroendocrine Tumor, Carcinoid, GEP-NET. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05477576?

The interventions under investigation include: Everolimus (DRUG), Sunitinib (DRUG), Lanreotide (DRUG), RYZ101 (DRUG), Octreotide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05477576?

This trial is sponsored by RayzeBio, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05477576 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial