NCT07165132PHASE1Recruiting
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
RayzeBio, Inc.
Start Date
12/3/2025
Completion Date
4/1/2033
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 with NETs and other selected solid tumors expressing SSTRs.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
RYZ401
Conditions
GEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NETSolid TumorSomatostatin Receptor
Locations
Research Facility
Iowa City, Iowa 52242
United States
Research Facility
Lexington, Kentucky 40536
United States
Research Facility
St Louis, Missouri 63104
United States
Research Facility
St Louis, Missouri 63110
United States
Research Facility
Columbus, Ohio 43210
United States
Research Facility
Nashville, Tennessee 37232
United States
Research Facility
Salt Lake City, Utah 84112
United States
Research Facility
Toronto, Ontario M5G 2C4
Canada
Research Facility
Montreal, Quebec H3T 1E2
Canada