Study Of RYZ401 In Subjects With Solid Tumors Expressing SSTRs.

Study Overview

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

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.

N/A

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

DRUG: RYZ401

RYZ401-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-02
First Submitted that Met QC Criteria 2025-09-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-10
First Posted (ESTIMATED) 2025-09-10	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation, Dose Expansion	DRUG: RYZ401 Ac-225

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dose Escalation, Dose Expansion

DRUG: RYZ401

Ac-225

Primary Outcome Measures	Measure Description	Time Frame
Dose Escalation	Incidence of DLTs during RYZ 401 Treatment	Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Dose Expansion	Incidence, severity, and duration of AEs	Cycle1 Day 1 to LPFV + 6 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: RayzeBio Clinical Trials

Phone Number: +1 619 657 0057

Email: clinicaltrials@rayzebio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

At least 18 years old at the time of signing the main study informed consent form (ICF).
Histologically confirmed:

Grades 1-3 WD NETs (dose escalation and dose expansion)
Meningioma (dose expansion only)
SSTR-positive disease, as assessed by SSTR-PET imaging
Adequate renal, hematologic and hepatic function

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Denis Ferreira, MD, RayzeBio, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record