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Recruiting NCT07165132

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

Phase I Interventional GEP-NET Gastroenteropancreatic Neuroendocrine Tumor Gastroenteropancreatic Neuroendocrine Tumor Disease Neuroendocrine Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RYZ401.
Who it may be relevant to
Registry conditions: GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Drug RYZ401
    Ac-225

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Research Facility — Iowa City
  • Research Facility — Lexington
  • Research Facility — St Louis
  • Research Facility — St Louis
  • Research Facility — Columbus
  • Research Facility — Nashville
  • Research Facility — Salt Lake City
Canada · 2 centers
  • Research Facility — Toronto
  • Research Facility — Montreal

Identifiers

NCT: NCT07165132 · RYZ401-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗