GEP-NET study: RYZ401
Official title Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
ClinicalTrials.gov ID: NCT07165132
What this study is testing
What is RYZ401?
An investigational injectable medicine being studied for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and other solid tumors that express somatostatin receptors.
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
- This study is testing whether RYZ401 is safe and how well it works in people with neuroendocrine tumors and other solid tumors that have SSTRs.
- Who it's for
- You may be able to join if you have a solid tumor that expresses SSTRs, such as a neuroendocrine tumor.
- What's involved
- You will receive RYZ401 in a controlled setting. The study will monitor your safety and check how the drug works.
- Time commitment
- The study lasts several weeks to months, with regular visits for drug administration and safety checks.
- 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
- WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital...
- SSTR-positive disease, as assessed by SSTR-PET imaging
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
- 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 is enrolling
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Los Angeles, California, United States; Jacksonville, Florida, United States; Iowa City, Iowa, United States; Lexington, Kentucky, United States; Rochester, Minnesota, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.