RecruitingPhase 1NCT07165132

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.

Sponsor

RayzeBio, Inc.

Enrollment

104 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumor Neuroendocrine Tumors Gep Net Carcinoid Tumor Gastroenteropancreatic Neuroendocrine Tumor Carcinoid Gastroenteropancreatic Neuroendocrine Tumor Disease Pancreatic NET Somatostatin Receptor

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

Min Age: 18 Years

Inclusion Criteria8

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