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NCT05477576 · ClinicalTrials.gov registry record · Phase 3
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
A Phase 3 study of Neuroendocrine Tumors and Carcinoid Tumor, sponsored by RayzeBio.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT05477576: Recruiting Phase 3 study of Neuroendocrine Tumors and Carcinoid Tumor, sponsored by RayzeBio.
NCT05477576 is a Phase 3 study of Neuroendocrine Tumors and Carcinoid Tumor that is actively recruiting participants, run by RayzeBio. The registered enrollment target is 288 participants, above the 174-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (66% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05477576, a Phase 3 study of Neuroendocrine Tumors and Carcinoid Tumor, is actively recruiting participants, sponsored by RayzeBio.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Incidence of DLTs during the first 56 days of study treatment will be assessed.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
What NCT05477576 shows while recruiting
NCT05477576 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (66% higher).
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.
NCT05477576 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
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.
What interventions are being tested in trial NCT05477576?
The interventions under investigation include: Everolimus (DRUG), Sunitinib (DRUG), Lanreotide (DRUG), RYZ101 (DRUG), Octreotide (DRUG).
Who is sponsoring clinical trial NCT05477576?
This trial is sponsored by RayzeBio, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05477576's enrollment target sits among peer trials
288 7th of 52 higher than 46 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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