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Recruiting

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

NCT07165132 · RayzeBio, Inc.
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Official title
Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.
About this study
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
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
Enrollment target: 104 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-03
Estimated completion: 2033-04
Last updated: 2026-09-15
Interventions
Drug: RYZ401
Primary outcomes
  • Dose Escalation (Incidence of DLTs during the first 4 weeks of RYZ401 treatment)
  • Dose Expansion (Cycle1 Day 1 to LPFV + 6 weeks)
Sponsor
RayzeBio, Inc. · industry
Contacts & investigators
ContactRayzeBio Clinical Trials · contact · clinicaltrials@rayzebio.com · +1 619 657 0057
InvestigatorYe Yuan, MD · study_director, RayzeBio, Inc.
All locations (14)
Research FacilityRecruiting
Phoenix, Arizona, United States
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Jacksonville, Florida, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Toronto, Ontario, Canada
Research FacilityRecruiting
Montreal, Quebec, Canada
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. · TrialPath