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Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

RecruitingPhase 1

Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: RayzeBio, Inc. · Participants: 104 · Started: Dec 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07165132

Locations in the U.S.

ArizonaResearch Facility, Phoenix
FloridaResearch Facility, Jacksonville
IowaResearch Facility, Iowa City
KentuckyResearch Facility, Lexington
MinnesotaResearch Facility, Rochester
MissouriResearch Facility, St Louis
Research Facility, St Louis
OhioResearch Facility, Columbus
OregonResearch Facility, Portland
TennesseeResearch Facility, Nashville
UtahResearch Facility, Salt Lake City
VirginiaResearch Facility, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.