RYZ101 Compared With SOC in Pts W/ Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed
1-800-641-2422
Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy
- Sex at Birth: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I
- Conditions Being Studied: Cancer - Gastrointestinal, Cancer - Pancreas
Study Purpose
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.
Locations
UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: Study20230751
- StudyID: RAYZ1223
- ClinicalTrials.gov: NCT05477576
1-800-641-2422
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