This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
RP3D as determined in Phase 1b
Everolimus
Sunitinib
High-dose octreotide
Lanreotide
Research Facility
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGResearch Facility
Duarte, California, United States
COMPLETEDResearch Facility
Irvine, California, United States
RECRUITINGResearch Facility
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGPhase 1b: RP3D
Incidence of DLTs during the first 56 days of study treatment will be assessed.
Time frame: 56 days of study treatment
Phase 3: PFS as determined by BICR
PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier.
Time frame: After the target number of 143 PFS events have occurred
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Facility
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGResearch Facility
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGResearch Facility
New Haven, Connecticut, United States
ACTIVE_NOT_RECRUITINGResearch Facility
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGResearch Facility
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGResearch Facility
Miami, Florida, United States
RECRUITING...and 44 more locations