Status:
NOT_YET_RECRUITING
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Lead Sponsor:
RayzeBio, Inc.
Conditions:
GEP-NET
Gastroenteropancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least 18 years old at the time of signing the main study informed consent form (ICF).
- Histologically confirmed:
- Grades 1-3 WD NETs (dose escalation and dose expansion)
- Meningioma (dose expansion only)
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07165132
Start Date
October 1 2025
End Date
October 1 2032
Last Update
September 10 2025
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