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Recruiting

NCT Number: NCT07165132

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RYZ401

Drug

Ac-225

Primary outcomes

  1. Dose Escalation

    Time frame: Incidence of DLTs during the first 4 weeks of RYZ401 treatment

    Incidence of DLTs during RYZ 401 Treatment

  2. Dose Expansion

    Time frame: Cycle1 Day 1 to LPFV + 6 weeks

    Incidence, severity, and duration of AEs

Study contacts

Contact information is provided by the study sponsor or research team.

RayzeBio Clinical Trials

CONTACT

[email protected]

+1 619 657 0057

Sponsors and collaborators

Lead sponsor

RayzeBio, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2033
First posted
Sep 10, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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