OncoMatch/Clinical Trials/NCT05477576
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Is NCT05477576 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for gep-net.
Treatment: RYZ101 · Everolimus · Sunitinib · Octreotide · Lanreotide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR overexpression (Krenning score 3 or 4 on SSTR-PET)
SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET
Required: SSTR imaging (at least 1 SSTR-PET imaging-positive measurable site of disease (RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative)
at least 1 SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative
Disease stage
Grade: 12 (Ki67)
Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: 177Lu-labeled somatostatin analog (177Lu-SSA)
progressive...GEP-NET...following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA
Cannot have received: radioembolization
Prior radioembolization
Cannot have received: peptide receptor radionuclide therapy other than Lu-177 SSA
Exception: not applicable for ad hoc subcohort of the PK/ECG substudy
PRRT other than Lu-177 SSA (not applicable for ad hoc subcohort of the PK/ECG substudy)
Lab requirements
Blood counts
Hemoglobin ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL; platelets ≥75 x 10^9/L
Kidney function
eGFR ≥60 mL/min/1.73 m2 (CKD-EPI)
Liver function
Total bilirubin ≤3 x upper limit normal (ULN)
Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2...Adequate hematologic function, defined by...Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL; platelets ≥75 x 10^9/L. Total bilirubin ≤3 x upper limit normal (ULN)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Facility · Phoenix, Arizona
- Research Facility · Duarte, California
- Research Facility · Irvine, California
- Research Facility · Los Angeles, California
- Research Facility · Palo Alto, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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