RYZ401 for solid tumors that express somatostatin receptors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label dose-escalation and dose-expansion trial of RYZ401 in adults with SSTR-positive neuroendocrine tumors (NETs) and selected other solid tumors. The dose-escalation phase seeks the recommended Phase 2 dose (RP2D) and optimal regimen, followed by expansion cohorts focused on GEP-NETs and other frequently SSTR-expressing indications. Key endpoints include safety, tolerability, and preliminary anti-tumor activity, with eligibility confirmed by SSTR-PET imaging and requirements for adequate organ function. Patients who previously received peptide receptor radionuclide therapy such as lutetium-177 are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Facility
  Phoenix, Arizona, United States Recruiting
• Research Facility
  Los Angeles, California, United States Recruiting
• Research Facility
  Jacksonville, Florida, United States Recruiting
• Research Facility
  Iowa City, Iowa, United States Recruiting
• Research Facility
  Lexington, Kentucky, United States Recruiting
• Research Facility
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: RayzeBio Clinical Trials
• Email: clinicaltrials@rayzebio.com
• Phone: +1 619 657 0057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.