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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07165132

Enrollment

104

Registered

2025-09-10

Start date

2025-12-03

Completion date

2033-04-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoid, Carcinoid Tumor, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, GEP-NET, Neuroendocrine Tumors, Pancreatic NET, Solid Tumor, Somatostatin Receptor

Keywords

Neuroendocrine Tumors, SSTR+, GEP-NET, Targeted Radiotherapy, Gastroenteropancreatic Neuroendocrine Tumor, Actinium, Ac 225, PRRT, Solid Tumor, Somatostatin Receptors, Radiopharmaceutical, BMS, Bristol Myers Squibb, Rayze, SSTR, RayzeBio, Well-differentiated NET, WD NETs

Brief 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.

Interventions

DRUGRYZ401

Ac-225

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada, United States

Contacts

CONTACTRayzeBio Clinical Trials

clinicaltrials@rayzebio.com+1 619 657 0057

STUDY_DIRECTORYe Yuan, MD

RayzeBio, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026