Actively Recruiting
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Led by RayzeBio, Inc. · Updated on 2026-04-13
104
Participants Needed
4
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of signing the main study informed consent form (ICF).
- Histologically confirmed Grades 1-3 well-differentiated (WD), metastatic or locally advanced and unresectable neuroendocrine tumors (NET) at any primary site, including gastrointestinal, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.
- Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable gastroenteropancreatic NETs.
- Dose Expansion Cohort B: Metastatic or locally advanced and unresectable tumors that frequently express somatostatin receptors, including WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (lung, thyroid, breast, urogenital, adrenal tumors), and meningioma (Grades 1-3).
- SSTR-positive disease, as assessed by SSTR-PET imaging.
- Adequate renal, hematologic, and hepatic function.
You will not qualify if you...
- Prior radiopharmaceutical therapy (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 infection, hepatitis B infection, or known active hepatitis C virus infection.
- Note: Additional criteria may apply and will be assessed by the study site.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Research Facility
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Research Facility
Lexington, Kentucky, United States, 40536
Actively Recruiting
3
Research Facility
St Louis, Missouri, United States, 63104
Actively Recruiting
4
Research Facility
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
RayzeBio Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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