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Clinical Trials in the USA / NCT07165132
Recruiting Phase 1

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

NCT07165132 · tracked via the Priya Life Science USA tracker
Sponsor
RayzeBio, Inc.
Phase
Phase 1
Started
2025-12-03
Last updated
2026-09-15

Condition(s) studied

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

Investigational drug(s) / intervention(s)

RYZ401

RYZ401: Ac-225

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Research Facility Phoenix Arizona Recruiting
Research Facility Jacksonville Florida Recruiting
Research Facility Iowa City Iowa Recruiting
Research Facility Lexington Kentucky Recruiting
Research Facility Rochester Minnesota Recruiting
Research Facility St Louis Missouri Recruiting
Research Facility St Louis Missouri Recruiting
Research Facility Columbus Ohio Recruiting
Research Facility Portland Oregon Recruiting
Research Facility Nashville Tennessee Recruiting
Research Facility Salt Lake City Utah Recruiting
Research Facility Charlottesville Virginia Recruiting
Research Facility Toronto Ontario Recruiting
Research Facility Montreal Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07165132 on ClinicalTrials.gov ↗ ← All trials in the USA