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Study of RYZ101 for Advanced GEP-NETs

This study is testing a drug called RYZ101 for people with advanced, inoperable gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have specific markers (SSTR-PET positive) and have continued to grow after treatment with 177Lu-SSA therapy. Researchers want to find the safest and most effective dose of RYZ101. They will compare RYZ101 to standard treatments like Everolimus, Sunitinib, Octreotide, or Lanreotide. To join, you must be at least 18 years old, have GEP-NETs that are well-differentiated (Grade 1-2), and have an ECOG status of 0-2. The main goal is to see how long people live without their cancer getting worse (PFS). The study is currently recruiting about 338 participants.

Study design
This interventional study aims to enroll 338 participants. It compares RYZ101 to standard care treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for Phase 3 measures progression-free survival after 143 events have occurred, indicating a long-term follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05477576

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
RayzeBio, Inc.
~338 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:RYZ101EverolimusSunitinibOctreotideLanreotide

At a glance

Recruiting sites
21 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b: RP3D
Measured over 56 days of study treatment
+1 more outcome measured

Conditions

GEP-NET
Gastroenteropancreatic Neuroendocrine Tumor
Gastroenteropancreatic Neuroendocrine Tumor Disease
Neuroendocrine Tumors
Carcinoid
Carcinoid Tumor
Pancreatic NET

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Where it's being run

54 sites across 30 states
France6
California5
Florida3
Belgium3
Brazil3
Netherlands3
Spain3
Massachusetts2

Study leadership

  • Ye Yuan, MD · STUDY_DIRECTOR · RayzeBio Sr. Medical Director

Who to contact

RayzeBio Clinical Trials
[email protected]
+1 619 657 0057
Email the study team

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What this trial measures

  • Phase 1b: RP3D56 days of study treatment

    Incidence of DLTs during the first 56 days of study treatment will be assessed.

  • Phase 3: PFS as determined by BICRAfter the target number of 143 PFS events have occurred

    PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier.