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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Dose Escalation — Incidence of DLTs during the first 4 weeks of RYZ401 treatment Incidence of DLTs during RYZ 401 Treatment
Dose Expansion — Cycle1 Day 1 to LPFV + 6 weeks Incidence, severity, and duration of AEs
Trial sites (14)
Facility
City
Region
Status
Research Facility
Phoenix
Arizona
Recruiting
Research Facility
Jacksonville
Florida
Recruiting
Research Facility
Iowa City
Iowa
Recruiting
Research Facility
Lexington
Kentucky
Recruiting
Research Facility
Rochester
Minnesota
Recruiting
Research Facility
St Louis
Missouri
Recruiting
Research Facility
St Louis
Missouri
Recruiting
Research Facility
Columbus
Ohio
Recruiting
Research Facility
Portland
Oregon
Recruiting
Research Facility
Nashville
Tennessee
Recruiting
Research Facility
Salt Lake City
Utah
Recruiting
Research Facility
Charlottesville
Virginia
Recruiting
Research Facility
Toronto
Ontario
Recruiting
Research Facility
Montreal
Quebec
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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