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

NCT05477576 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

RYZ101

RP3D as determined in Phase 1b

DRUG

Everolimus

Everolimus

DRUG

Sunitinib

Sunitinib

DRUG

Octreotide

High-dose octreotide

DRUG

Lanreotide

Lanreotide

Sponsors & Collaborators

  • RayzeBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Ye Yuan, MD · RayzeBio Sr. Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2026-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • France
  • Netherlands
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477576 on ClinicalTrials.gov