Trials / Recruiting
RecruitingNCT07165132
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.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- RayzeBio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RYZ401 | Ac-225 |
Timeline
- Start date
- 2025-12-03
- Primary completion
- 2027-02-01
- Completion
- 2033-04-01
- First posted
- 2025-09-10
- Last updated
- 2026-04-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07165132. Inclusion in this directory is not an endorsement.