Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Recruiting now · Phase 1
Conditions studied: GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET, Solid Tumor, Somatostatin Receptor
In brief
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.
Key facts
- Study ID
- NCT07165132
- Run by
- RayzeBio, Inc.
- People needed
- 104
- Starts
- 2025-12-03
- Expected to finish
- 2033-04-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Facility — Iowa City, Iowa, United States (enrolling)
- Research Facility — Lexington, Kentucky, United States (enrolling)
- Research Facility — St Louis, Missouri, United States (enrolling)
- Research Facility — St Louis, Missouri, United States (enrolling)
- Research Facility — Columbus, Ohio, United States (enrolling)
- Research Facility — Nashville, Tennessee, United States (enrolling)
- Research Facility — Salt Lake City, Utah, United States (enrolling)
- Research Facility — Toronto, Ontario, Canada (enrolling)
- Research Facility — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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