RYZ401 for solid tumors that express somatostatin receptors
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.
This trial will try RYZ401, a targeted radiotherapy, in adults with neuroendocrine or other solid tumors that show somatostatin receptors to find a safe dose and see if it shrinks tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RayzeBio, Inc. Industry-sponsored |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Trial ID | NCT07165132 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label dose-escalation and dose-expansion trial of RYZ401 in adults with SSTR-positive neuroendocrine tumors (NETs) and selected other solid tumors. The dose-escalation phase seeks the recommended Phase 2 dose (RP2D) and optimal regimen, followed by expansion cohorts focused on GEP-NETs and other frequently SSTR-expressing indications. Key endpoints include safety, tolerability, and preliminary anti-tumor activity, with eligibility confirmed by SSTR-PET imaging and requirements for adequate organ function. Patients who previously received peptide receptor radionuclide therapy such as lutetium-177 are excluded.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed well-differentiated (Grade 1–3) metastatic or unresectable NETs or other SSTR-positive solid tumors, measurable disease on SSTR-PET, and adequate renal, hepatic, and hematologic function are the intended candidates.
Not a fit: Patients whose tumors lack SSTR expression, those with prior peptide receptor radionuclide therapy such as Lu-177, or those with inadequate organ function are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, RYZ401 could offer a new targeted radiotherapy option that shrinks or stabilizes SSTR-positive NETs while maintaining a manageable safety profile.
How similar studies have performed: Related SSTR-targeted radiotherapies, most notably 177Lu-DOTATATE, have shown clinical benefit in GEP-NETs, so this approach builds on established radioligand therapy while testing a different agent.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa and 3 other locations
- Research Facility — Iowa City, Iowa, United States (Recruiting)
- Research Facility — Lexington, Kentucky, United States (Recruiting)
- Research Facility — St Louis, Missouri, United States (Recruiting)
- Research Facility — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: RayzeBio Clinical Trials
- Email: clinicaltrials@rayzebio.com
- Phone: +1 619 657 0057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.