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RecruitingInterventionalPhase 1

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.

NCT ID: NCT07165132Sponsor: RayzeBio, Inc.Last updated: 2026-06-09

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.

Arms & interventions

  • DrugRYZ401

    Ac-225

Outcome measures

Primary

  • Dose Escalation

    Incidence of DLTs during RYZ 401 Treatment

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

  • Dose Expansion

    Incidence, severity, and duration of AEs

    Time frame: Cycle1 Day 1 to LPFV + 6 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Research Facility

Iowa City, Iowa, 52242

Recruiting

Research Facility

Lexington, Kentucky, 40536

Recruiting

Research Facility

St Louis, Missouri, 63104

Recruiting

Research Facility

St Louis, Missouri, 63110

Recruiting

Research Facility

Columbus, Ohio, 43210

Recruiting

Research Facility

Nashville, Tennessee, 37232

Recruiting

Research Facility

Salt Lake City, Utah, 84112

Recruiting