GEP-NETPhase 1NCT07165132
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
A Phase 1 study testing RYZ401 in people with GEP-NET and Gastroenteropancreatic Neuroendocrine Tumor, run by RayzeBio, Inc. at 15 sites in 2 countries.
Trial summary
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease
- What is being tested?
- RYZ401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 3 Dec 2025to Apr 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States13 sites, 13 recruiting
- Recruiting
Research Facility
Charlottesville, Virginia, 22903
- Recruiting
Research Facility
Columbus, Ohio, 43210
- Recruiting
Research Facility
Iowa City, Iowa, 52242
- Recruiting
Research Facility
Jacksonville, Florida, 32224
- Recruiting
Research Facility
Lexington, Kentucky, 40536
- Recruiting
Research Facility
Los Angeles, California, 90095
- Recruiting
Research Facility
Nashville, Tennessee, 37232
- Recruiting
Research Facility
Phoenix, Arizona, 85054
- Recruiting
Research Facility
Portland, Oregon, 97239
- Recruiting
Research Facility
Rochester, Minnesota, 55905
- Recruiting
Research Facility
Salt Lake City, Utah, 84112
- Recruiting
Research Facility
St Louis, Missouri, 63104
- Recruiting
Research Facility
St Louis, Missouri, 63110
Canada2 sites, 2 recruiting
- Recruiting
Research Facility
Montreal, Quebec, H3T 1E2
- Recruiting
Research Facility
Toronto, Ontario, M5G 2M9
About this study
Official title: Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.
- Conditions
- GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor
- Being tested
- RYZ401
- Keywords
- Neuroendocrine Tumors, SSTR+, GEP-NET, Targeted Radiotherapy, Gastroenteropancreatic Neuroendocrine Tumor, Actinium, Ac 225, PRRT, Solid Tumor, Somatostatin Receptors, Radiopharmaceutical, BMS, Bristol Myers Squibb, Rayze, SSTR, RayzeBio, Well-differentiated NET, WD NETs
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors, Carcinoid Tumor, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RYZ401Drug
Ac-225
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation, Dose Expansion | Experimental | Not described Receives: Drug: RYZ401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
Incidence of DLTs during RYZ 401 Treatment
Measured: Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Dose Expansion
Incidence, severity, and duration of AEs
Measured: Cycle1 Day 1 to LPFV + 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start3 Dec 2025
- Primary completionFeb 2027 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GEP-NETStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RayzeBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Yuan, MD, Study director, RayzeBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165132
- Sponsor's protocol ID
- RYZ401-101
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.
- ClinicalTrials.gov ID
- NCT07165132
- Acronym / sponsor ID
- RYZ401-101
- Conditions
- GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor
- Keywords
- Neuroendocrine Tumors, SSTR+, GEP-NET, Targeted Radiotherapy, Gastroenteropancreatic Neuroendocrine Tumor, Actinium, Ac 225, PRRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- RayzeBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation, Dose Expansion | Experimental | Drug: RYZ401 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- Prior RPT, including Lu-177.
- Prior solid organ or bone marrow transplantation.
- Use of chronic systemic steroid therapy.
- Significant cardiovascular disease
- Resistant hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RYZ401Ac-225 | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Dose Escalation
Time frame: Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Incidence of DLTs during RYZ 401 Treatment
Dose Expansion
Time frame: Cycle1 Day 1 to LPFV + 6 weeks
Incidence, severity, and duration of AEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ye Yuan, MD study director
RayzeBio, Inc.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RYZ401 in people with GEP-NET and Gastroenteropancreatic Neuroendocrine Tumor, run by RayzeBio, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RayzeBio Clinical Trials (+1 619 657 0057, clinicaltrials@rayzebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation (time frame: Incidence of DLTs during the first 4 weeks of RYZ401 treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.