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New radioactive drug aims to fight gut tumors that resist standard therapy

NCT ID NCT05477576

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called RYZ101 in people with advanced neuroendocrine tumors (GEP-NETs) that have grown after prior radiation therapy. The trial has two parts: first finding the right dose, then comparing RYZ101 to standard treatments like everolimus or sunitinib. About 338 participants will be enrolled to see if RYZ101 can slow tumor growth better than current options.

What this could mean

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

Active substance
RYZ101 (a radioactive drug targeting somatostatin receptors)
What this could lead to
If successful, RYZ101 could offer a new treatment option for people with advanced GEP-NETs whose cancer has worsened after initial targeted radiation therapy.
What could go wrong
This is an early-to-mid stage trial (Phase 1b/3), so results are not guaranteed. RYZ101 may not be more effective than standard treatments and could cause side effects from radiation exposure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 338 people

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

Started

Mar 2022

Expected to finish

Dec 2030

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: * Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2. Ki67% \<20% is not required for the ad hoc subcohort of the PK/ECG substudy. * Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA (archival tissue is not required for the ad hoc subcohort of the PK/ECG substudy). No time limit is defined between 177Lu-SSA treatment and randomization. There must be at least 1 SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative. * Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) (Levey et al. 2009) * Adequate hematologic function, defined by the following laboratory results: * Part 2: Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL (≥1000 cells/mm3); platelets ≥75 x 109/L (75 x 103/mm3). * Total bilirubin ≤3 x upper limit normal (ULN) * Serum albumin ≥3.0 g/dL unless prothrombin time is within the normal range Exclusion: * Prior radioembolization * Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II heart failure, left ventricular ejection fraction (LVEF) \<40% or QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 ms for males and \>470 ms for females. * Resistant hypertension, defined as uncontrolled blood pressure (BP) \>140/90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton et al. 2018) * Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8% * PRRT other than Lu-177 SSA (not applicable for ad hoc subcohort of the PK/ECG substudy) * Any condition requiring systemic treatment with high-dose glucocorticoids within 14 days prior to first dose of study treatment and/or which cannot be stopped while on study. Inhaled or topical steroids are permitted. * Prior history of liver cirrhosis or liver transplantation

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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 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

How to take part

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

  1. The places running it

    21 sites in 5 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

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Research Facility

    COMPLETED

    Duarte, California, 91010, United States

  • Research Facility

    RECRUITING

    Irvine, California, 92663, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Palo Alto, California, 94305, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    New Haven, Connecticut, 06510, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Facility

    RECRUITING

    Miami, Florida, 33165, United States

  • Research Facility

    RECRUITING

    Tampa, Florida, 33607, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Facility

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Research Facility

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Research Facility

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02118, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Facility

    COMPLETED

    Troy, Michigan, 48098, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Facility

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Facility

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    New York, New York, 10029, United States

  • Research Facility

    RECRUITING

    New York, New York, 10065, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Facility

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Research Facility

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Research Facility

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Research Facility

    RECRUITING

    Seattle, Washington, 98109, United States

  • Research Facility

    RECRUITING

    Brussels, Belgium

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Leuven, Belgium

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Roeselare, Belgium

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Brasília, Brazil

  • Research Facility

    COMPLETED

    Rio de Janeiro, Brazil

  • Research Facility

    ACTIVE_NOT_RECRUITING

    São Paulo, Brazil

  • Research Facility

    ACTIVE_NOT_RECRUITING

    London, Ontario, Canada

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, Canada

  • Research Facility

    RECRUITING

    Clichy, France

  • Research Facility

    RECRUITING

    Lille, France

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Montpellier, France

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Nantes, France

  • Research Facility

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Villejuif, France

  • Research Facility

    RECRUITING

    Amsterdam, Netherlands

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Maastricht, Netherlands

  • Research Facility

    RECRUITING

    Utrecht, Netherlands

  • Research Facility

    ACTIVE_NOT_RECRUITING

    Seoul, South Korea

  • Research Facility

    RECRUITING

    Barcelona, Spain

  • Research Facility

    RECRUITING

    Madrid, Spain

  • Research Facility

    COMPLETED

    Zaragoza, Spain

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