Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official 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.

Keywords

GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET, Solid Tumor, Somatostatin Receptor, SSTR+, Targeted Radiotherapy, Actinium, Ac 225, PRRT, Somatostatin Receptors, Radiopharmaceutical, BMS, Bristol Myers Squibb, Rayze, SSTR, RayzeBio, Well-differentiated NET, WD NETs, Gastro-enteropancreatic neuroendocrine tumor, Islet Cell Adenoma, RYZ401

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

Note: Additional criteria may apply and will be assessed by the study site

Locations

  • Research Facility accepting new patients
    Los Angeles California 90095 United States
  • Research Facility accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RayzeBio, Inc.
ID
NCT07165132
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 104 study participants
Last Updated