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.
At least 18 years old at the time of signing the main study informed consent form (ICF).
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
Prior RPT, including Lu-177.
Prior solid organ or bone marrow transplantation.
Use of chronic systemic steroid therapy.
Significant cardiovascular disease
Sequential
RYZ401
DrugAc-225
Dose Escalation
Incidence of DLTs during RYZ 401 Treatment
Dose Expansion
Incidence, severity, and duration of AEs
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