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
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Research Facility
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Research Facility
St Louis, Missouri 63104
St Louis, Missouri 63104
Research Facility
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
More Details
- Status
- Recruiting
- Sponsor
- RayzeBio, Inc.