Tests RYZ401, a radiopharmaceutical treatment, in people with neuroendocrine tumors
Tests RYZ401, a radiation-carrying drug, in adults with somatostatin receptor tumors.
Plain-language title generated from the registry record
Registry title: Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Key facts
- Where
- Charlottesville, Columbus, Iowa City, Jacksonville, Lexington, Los Angeles, Nashville, Phoenix, Portland, Rochester, Salt Lake City, and St Louis, United StatesSee the 12 sites
- Phase
- Phase 1
Where in United States
- CharlottesvilleCharlottesville, United StatesTaking people
- ColumbusColumbus, United StatesTaking people
- Iowa CityIowa City, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- LexingtonLexington, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- NashvilleNashville, United StatesTaking people
- PhoenixPhoenix, United StatesTaking people
- PortlandPortland, United StatesTaking people
- RochesterRochester, United StatesTaking people
- Salt Lake CitySalt Lake City, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RayzeBio, Inc.
- Trial code
- NCT07165132
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: Prior RPT, including Lu-177; Prior solid organ or bone marrow transplantation; Use of chronic systemic steroid therapy; Prior history of liver cirrhosis; Significant cardiovascular disease; Resistant hypertension; Uncontrolled diabetes; HIV, hepatitis B infection or known active hepatitis C virus infection; Note: Additional criteria may apply and will be assessed by the study site.