NCT07165132 Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
| NCT ID | NCT07165132 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | RayzeBio, Inc. |
| Condition | GEP-NET |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2025-12-03 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ye Yuan, MD
STUDY DIRECTOR
RayzeBio, Inc.
Frequently Asked Questions
Who can join the NCT07165132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying GEP-NET. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07165132 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07165132 currently recruiting?
Yes, NCT07165132 is actively recruiting participants. Contact the research team at clinicaltrials@rayzebio.com for enrollment information.
Where is the NCT07165132 trial being conducted?
This trial is being conducted at Iowa City, United States, Lexington, United States, St Louis, United States, St Louis, United States and 5 additional locations.
Who is sponsoring the NCT07165132 clinical trial?
NCT07165132 is sponsored by RayzeBio, Inc.. The principal investigator is Ye Yuan, MD at RayzeBio, Inc.. The trial plans to enroll 104 participants.