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New treatment option for GEP-NET
Official title Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
ClinicalTrials.gov ID: NCT07165132
What this study is testing
What is RYZ401?
RYZ401 is an investigational medicine, being studied as a potential treatment for gep-net.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Lexington, Kentucky, United States; St Louis, Missouri, United States; Columbus, Ohio, United States; Nashville, Tennessee, United States; Salt Lake City, Utah, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.