Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Research Facility, Iowa City, Iowa, United States
• Research Facility, Lexington, Kentucky, United States
• Research Facility, St Louis, Missouri, United States
• Research Facility, St Louis, Missouri, United States
• Research Facility, Columbus, Ohio, United States
• Research Facility, Nashville, Tennessee, United States
• Research Facility, Salt Lake City, Utah, United States
• Research Facility, Toronto, Ontario, Canada
• Research Facility, Montreal, Quebec, Canada

Who to contact

RayzeBio Clinical Trials · +1 619 657 0057 · clinicaltrials@rayzebio.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07165132.