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NCT07165132PHASE1Recruiting

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

RayzeBio, Inc.

Start Date

12/3/2025

Completion Date

4/1/2033

Summary

The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * At least 18 years old at the time of signing the main study informed consent form (ICF). * Histologically confirmed: Dose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors. * Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs * Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications: * WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3) * SSTR-positive disease, as assessed by SSTR-PET imaging * Adequate renal, hematologic and hepatic function Exclusion criteria: * Prior RPT, including Lu-177. * Prior solid organ or bone marrow transplantation. * Use of chronic systemic steroid therapy. * Significant cardiovascular disease * Resistant hypertension * Uncontrolled diabetes * Prior history of liver cirrhosis * HIV, hepatitis B infection or known active hepatitis C virus infection. Note: Additional criteria may apply and will be assessed by the study site

Interventions

DRUG

RYZ401

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Conditions

GEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NETSolid TumorSomatostatin Receptor

Locations

Research Facility

Iowa City, Iowa 52242

United States

Research Facility

Lexington, Kentucky 40536

United States

Research Facility

St Louis, Missouri 63104

United States

Research Facility

St Louis, Missouri 63110

United States

Research Facility

Columbus, Ohio 43210

United States

Research Facility

Nashville, Tennessee 37232

United States

Research Facility

Salt Lake City, Utah 84112

United States

Research Facility

Toronto, Ontario M5G 2C4

Canada

Research Facility

Montreal, Quebec H3T 1E2

Canada