104 Participants NeededMy employer runs this trial

RYZ401 for Neuroendocrine Tumors

Recruiting at 12 trial locations
RC
Overseen ByRayzeBio Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RYZ401 for individuals with neuroendocrine tumors (NETs) and other tumors with specific cell markers. The trial aims to determine the optimal dose, assess safety, and evaluate effectiveness. Candidates include those with metastatic or advanced NETs that are inoperable. A PET scan showing specific markers (SSTR) on tumors and good kidney and liver health may qualify participants. Eligibility excludes those who have received certain prior treatments or have uncontrolled health issues like high blood pressure or diabetes. As a Phase 1 trial, this research seeks to understand how RYZ401 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those using chronic systemic steroid therapy, so you may need to discuss your specific medications with the study team.

Is there any evidence suggesting that RYZ401 is likely to be safe for humans?

Research shows that RYZ401, a new treatment for neuroendocrine tumors (NETs), is still undergoing safety testing in people. Earlier studies found RYZ401 promising, as it might deliver more effective radiation to tumors than treatments like DOTATATE. This suggests it could target tumors more precisely while potentially causing less harm to other body parts.

Current research focuses on determining the best dose and assessing how well people tolerate it. Since these studies are in the early stages, they primarily evaluate safety before progressing to larger trials. So far, a few patients have received this drug, and researchers are closely monitoring for any side effects to ensure its safety for broader use in the future.12345

Why do researchers think this study treatment might be promising for neuroendocrine tumors?

Most treatments for neuroendocrine tumors, such as somatostatin analogs and targeted therapies, focus on slowing tumor growth or managing symptoms. However, RYZ401 is unique because it employs a novel mechanism of action that directly targets and inhibits specific pathways involved in tumor cell growth and proliferation. This targeted approach may offer more precise intervention, potentially leading to more effective tumor control with fewer side effects. Researchers are excited about RYZ401 because it represents a new frontier in how these tumors can be treated, offering hope for improved outcomes in patients who may not respond well to existing therapies.

What evidence suggests that RYZ401 might be an effective treatment for neuroendocrine tumors?

Research has shown that RYZ401, a new type of medicine, could help treat neuroendocrine tumors. This trial will explore the effects of RYZ401, which laboratory studies have shown to deliver more radiation directly to tumors than DOTATATE, a similar treatment. This suggests it might better target and shrink tumors while reducing radiation exposure to the kidneys. Additionally, early results from clinical trials indicate that actinium-225, the radioactive component of RYZ401, produced positive outcomes. These findings suggest that RYZ401 could offer a new and possibly more effective treatment option for people with neuroendocrine tumors.12356

Who Is on the Research Team?

YY

Ye Yuan, MD

Principal Investigator

RayzeBio, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic solid tumors, like neuroendocrine tumors (NETs), that have a specific marker called SSTR. Participants must have good kidney, liver, and blood function. People can't join if they've had similar treatments before, uncontrolled diabetes, serious heart issues, organ transplants, severe high blood pressure, or active infections like HIV or hepatitis.

Inclusion Criteria

I have grade 1-3, well-differentiated, advanced or metastatic GEP-NETs that can't be removed by surgery.
I am at least 18 years old.
I have a confirmed, advanced neuroendocrine tumor that cannot be removed by surgery.
See 1 more

Exclusion Criteria

I have received radiopharmaceutical therapy before, including Lu-177.
My diabetes is not well controlled.
I have had a solid organ or bone marrow transplant.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RYZ401 treatment with dose escalation and expansion phases

4 weeks
Weekly visits for dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • RYZ401

Trial Overview

The study is testing a new drug called RYZ401 in people with NETs and other solid tumors that show the SSTR marker. The main goals are to find the best dose and see how safe it is. All participants receive RYZ401; there’s no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dose Escalation, Dose ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RayzeBio, Inc.

Lead Sponsor

Trials
6
Recruited
540+

Citations

expansion study of RYZ401, a novel radiopharmaceutical ...

Preclinical data have shown an improved therapeutic window versus DOTATATE. RYZ401 has the potential to deliver higher radiation doses to tumors ...

Study of RYZ401 in Subjects With Solid Tumors Expressing ...

The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate ...

expansion study of RYZ401, a novel radiopharmaceutical

Preclinical studies showed that RYZ401 delivered high radiation doses to tumors, with good renal clearance and low kidney-absorbed doses compared with DOTATATE, ...

A phase 1 first-in-human, dose-escalation and...

Preclinical data have shown an improved therapeutic window versus DOTATATE. RYZ401 has the potential to deliver higher radiation doses to tumors, with improved ...

expansion study of RYZ401, a novel radiopharmaceutical ...

Use of the a-emitter 225 Ac as the radioactive component has shown promising results in clinical studies: initial data from ACTION-1 suggest promising efficacy ...

First Three Patients Treated with Novel Theranostics Drug ...

The Phase 1 first-in-human (NCT07165132) clinical trial evaluates RYZ401's safety, tolerability, and early signs of effectiveness. The study is ...