Recruiting
Phase 1

RYZ401

Sponsor:

RayzeBio, Inc.

Code:

NCT07165132

Conditions

GEP-NET

Gastroenteropancreatic Neuroendocrine Tumor

Gastroenteropancreatic Neuroendocrine Tumor Disease

Neuroendocrine Tumors

Carcinoid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RYZ401

Study Details

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.

Conditions

GEP-NET

Gastroenteropancreatic Neuroendocrine Tumor

Gastroenteropancreatic Neuroendocrine Tumor Disease

Neuroendocrine Tumors

Carcinoid

Study ID

NCT07165132

Start date

Dec 3, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2033

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

104 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation, Dose Expansion

Interventions

RYZ401

Ac-225

Primary outcome measure

  • Dose Escalation [ Time Frame: Incidence of DLTs during the first 4 weeks of RYZ401 treatment ]
  • Dose Expansion [ Time Frame: Cycle1 Day 1 to LPFV + 6 weeks ]

Central Contacts and Locations

Central contacts

RayzeBio Clinical Trials

+1 619 657 0057clinicaltrials@rayzebio.com

Locations

Research Facility

Recruiting

Iowa City, Iowa, United States, 52242

Research Facility

Recruiting

Lexington, Kentucky, United States, 40536

Research Facility

Recruiting

St Louis, Missouri, United States, 63104

Research Facility

Recruiting

St Louis, Missouri, United States, 63110

Research Facility

Recruiting

Columbus, Ohio, United States, 43210

Research Facility

Recruiting

Nashville, Tennessee, United States, 37232

Research Facility

Recruiting

Salt Lake City, Utah, United States, 84112

Research Facility

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Research Facility

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

RayzeBio, Inc.

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RayzeBio, Inc. on 2026-06-09.