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Radioactive drug takes aim at Hard-to-Treat tumors

NCT ID NCT07165132

Disease control Sponsor: RayzeBio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This early-phase trial tests a new radioactive drug called RYZ401 in people with neuroendocrine tumors and other solid tumors that have a specific protein on their surface. The drug delivers a powerful radioactive particle directly to cancer cells. The study aims to find the safest dose and see if it shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RYZ401 (a radioactive drug containing Actinium-225)
What this could lead to
If it works, this could point toward a new treatment option for people with neuroendocrine tumors that are hard to treat.
What could go wrong
This is a very early Phase 1 trial with only 104 participants, so it may not work or could have unexpected side effects. The radioactive drug may cause damage to healthy organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Adenoma, Islet Cell carcinoid tumor digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2 meningioma neoplasm neuroendocrine neoplasm pancreatic neuroendocrine tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoid Carcinoid tumor Gastroenteropancreatic neuroendocrine tumor Gastroenteropancreatic neuroendocrine tumor disease Gep-net Neuroendocrine tumors Pancreatic net Solid tumor Somatostatin receptor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Facility

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Research Facility

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Facility

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Research Facility

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Research Facility

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Facility

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Research Facility

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Facility

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Research Facility

    RECRUITING

    Portland, Oregon, 97239, United States

  • Research Facility

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Facility

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Research Facility

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Research Facility

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Research Facility

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

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