NCT07165132RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
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.
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 3 Dec 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- RayzeBio, Inc.
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07165132
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 104
- From 3 Dec 2025 to the primary completion date, Feb 2027
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior RPT, including Lu-177.
- Prior solid organ or bone marrow transplantation.
- Use of chronic systemic steroid therapy.
- Prior history of liver cirrhosis
Other illness
- Significant cardiovascular disease
- Resistant hypertension
- Uncontrolled diabetes
- HIV, hepatitis B infection or known active hepatitis C virus infection.
- Note: Additional criteria may apply and will be assessed by the study site
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.