Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Purpose
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
- GEP-NET
- Gastroenteropancreatic Neuroendocrine Tumor
- Gastroenteropancreatic Neuroendocrine Tumor Disease
- Neuroendocrine Tumors
- Carcinoid
- Carcinoid Tumor
- Pancreatic NET
- Solid Tumor
- Somatostatin Receptor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation, Dose Expansion |
|
Recruiting Locations
Research Facility
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- RayzeBio, Inc.