Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
RYZ101: RP3D as determined in Phase 1b
Everolimus: Everolimus
Sunitinib: Sunitinib
Octreotide: High-dose octreotide
Lanreotide: Lanreotide
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase 1b: RP3D — 56 days of study treatment
Incidence of DLTs during the first 56 days of study treatment will be assessed. - Phase 3: PFS as determined by BICR — After the target number of 143 PFS events have occurred
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.
Trial sites (54)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Facility | Phoenix | Arizona | |
| Research Facility | Duarte | California | |
| Research Facility | Irvine | California | |
| Research Facility | Los Angeles | California | |
| Research Facility | Palo Alto | California | |
| Research Facility | San Francisco | California | |
| Research Facility | New Haven | Connecticut | |
| Research Facility | Washington D.C. | District of Columbia | |
| Research Facility | Jacksonville | Florida | |
| Research Facility | Miami | Florida | |
| Research Facility | Tampa | Florida | |
| Research Facility | Atlanta | Georgia | |
| Research Facility | Iowa City | Iowa | |
| Research Facility | Lexington | Kentucky | |
| Research Facility | Glen Burnie | Maryland | |
| Research Facility | Boston | Massachusetts | |
| Research Facility | Boston | Massachusetts | |
| Research Facility | Troy | Michigan | |
| Research Facility | Rochester | Minnesota | |
| Research Facility | St Louis | Missouri | |
| Research Facility | Omaha | Nebraska | |
| Research Facility | New York | New York | |
| Research Facility | New York | New York | |
| Research Facility | Cleveland | Ohio | |
| Research Facility | Columbus | Ohio | |
| Research Facility | Portland | Oregon | |
| Research Facility | Philadelphia | Pennsylvania | |
| Research Facility | Pittsburgh | Pennsylvania | |
| Research Facility | Nashville | Tennessee | |
| Research Facility | Houston | Texas | |
| Research Facility | Salt Lake City | Utah | |
| Research Facility | Seattle | Washington | |
| Research Facility | Brussels | Belgium | |
| Research Facility | Leuven | Belgium | |
| Research Facility | Roeselare | Belgium | |
| Research Facility | Brasília | Brazil | |
| Research Facility | Rio de Janeiro | Brazil | |
| Research Facility | São Paulo | Brazil | |
| Research Facility | London | Ontario | |
| Research Facility | Toronto | Ontario |
+ 14 more sites — see the full list on the official registry below.
Other trials for the same condition
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.
View NCT05477576 on ClinicalTrials.gov ↗ ← All trials in Belgium