Clinical Trials in the USA / NCT07165132
Recruiting
Phase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
NCT07165132 · tracked via the Priya Life Science USA tracker
Condition(s) studied
GEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NETSolid TumorSomatostatin Receptor
Investigational drug(s) / intervention(s)
RYZ401
RYZ401: Ac-225
Study 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.
Eligibility
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
Primary outcome measure(s)
- Dose Escalation — Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Incidence of DLTs during RYZ 401 Treatment - Dose Expansion — Cycle1 Day 1 to LPFV + 6 weeks
Incidence, severity, and duration of AEs
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Facility | Phoenix | Arizona | Recruiting |
| Research Facility | Jacksonville | Florida | Recruiting |
| Research Facility | Iowa City | Iowa | Recruiting |
| Research Facility | Lexington | Kentucky | Recruiting |
| Research Facility | Rochester | Minnesota | Recruiting |
| Research Facility | St Louis | Missouri | Recruiting |
| Research Facility | St Louis | Missouri | Recruiting |
| Research Facility | Columbus | Ohio | Recruiting |
| Research Facility | Portland | Oregon | Recruiting |
| Research Facility | Nashville | Tennessee | Recruiting |
| Research Facility | Salt Lake City | Utah | Recruiting |
| Research Facility | Charlottesville | Virginia | Recruiting |
| Research Facility | Toronto | Ontario | Recruiting |
| Research Facility | Montreal | Quebec | Recruiting |
More RayzeBio, Inc. trials in the USA
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
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RYZ711 Diagnostic Platform Study
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Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
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Other trials for the same condition
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07165132 on ClinicalTrials.gov ↗ ← All trials in the USA