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Study of RYZ401 for Neuroendocrine and Other Solid Tumors

This study is testing a treatment called RYZ401 (Ac-225) in people with neuroendocrine tumors (NETs) and other solid tumors that express SSTRs (somatostatin receptors, which are proteins found on some cancer cells). The main goals are to find the best dose of RYZ401, understand its safety and side effects, and see how well it works. You might be able to join if you are at least 18 years old and have a confirmed diagnosis of metastatic or locally advanced NET that cannot be removed by surgery. The study aims to enroll 104 participants. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. The study aims to enroll 104 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured during the first 4 weeks of RYZ401 treatment and from Cycle 1 Day 1 to the last patient's final visit plus 6 weeks.

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NCT07165132

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

Recruiting
PHASE1Ages 18+InterventionalTreatment
RayzeBio, Inc.
~104 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:RYZ401

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation
Measured over Incidence of DLTs during the first 4 weeks of RYZ401 treatment
+1 more outcome measured

Conditions

GEP-NET
Gastroenteropancreatic Neuroendocrine Tumor
Gastroenteropancreatic Neuroendocrine Tumor Disease
Neuroendocrine Tumors
Carcinoid
Carcinoid Tumor
Pancreatic NET
Solid Tumor
Somatostatin Receptor

Explore related trials

Digestive System Neuroendocrine TumorMeningiomaNeuroendocrine NeoplasmSolid NeoplasmSomatostatin Receptor

Where it's being run

9 sites across 8 states
Missouri2
Iowa1
Kentucky1
Ohio1
Tennessee1
Utah1
Ontario1
Quebec1

Study leadership

  • Ye Yuan, MD · STUDY_DIRECTOR · RayzeBio, Inc.

Who to contact

RayzeBio Clinical Trials
[email protected]
+1 619 657 0057
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18 years old at the time of signing the main study informed consent form (ICF).
Histologically confirmed:
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

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.

What this trial measures

  • Dose EscalationIncidence of DLTs during the first 4 weeks of RYZ401 treatment

    Incidence of DLTs during RYZ 401 Treatment

  • Dose ExpansionCycle1 Day 1 to LPFV + 6 weeks

    Incidence, severity, and duration of AEs