NCT07165132

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
84mo left

Started Dec 2025

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Dec 2025Apr 2033

First Submitted

Initial submission to the registry

August 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2033

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

August 20, 2025

Last Update Submit

April 6, 2026

Conditions

GEP-NETGastroenteropancreatic Neuroendocrine TumorNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NETSolid TumorSomatostatin ReceptorGastroenteropancreatic Neuroendocrine Tumor Disease

Keywords

Neuroendocrine TumorsSSTR+GEP-NETTargeted RadiotherapyGastroenteropancreatic Neuroendocrine TumorActiniumAc 225PRRTSolid TumorSomatostatin ReceptorsRadiopharmaceuticalBMSBristol Myers SquibbRayzeSSTRRayzeBioWell-differentiated NETWD NETs

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Dose Escalation, Dose Expansion

EXPERIMENTAL
Drug: RYZ401

Interventions

RYZ401DRUG

Ac-225

Dose Escalation, Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Facility

Iowa City, Iowa, 52242, United States

RECRUITING

Research Facility

Lexington, Kentucky, 40536, United States

RECRUITING

Research Facility

St Louis, Missouri, 63104, United States

RECRUITING

Research Facility

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumorNeuroendocrine TumorsCarcinoid TumorAdenoma, Islet Cell

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialAdenomaPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ye Yuan, MD

    RayzeBio, Inc.

    STUDY DIRECTOR

Central Study Contacts

RayzeBio Clinical Trials

CONTACT

+1 619 657 0057clinicaltrials@rayzebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 10, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2033

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(4)