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Clinical Trials in Canada / NCT05477576
Recruiting Phase 3

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

NCT05477576 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2022-03-24
Last updated
2026-03-30

Condition(s) studied

GEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NET

Investigational drug(s) / intervention(s)

RYZ101 →Everolimus →Sunitinib →Octreotide →Lanreotide →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion: * Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2. Ki67% \<20% is not required for the ad hoc subcohort of the PK/ECG substudy. * Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA (archival tissue is not required for the ad hoc subcohort of the PK/ECG substudy). No time limit is defined between 177Lu-SSA treatment and randomization. There must be 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. * Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) (Levey et al. 2009) * Adequate hematologic function, defined by the following laboratory results: * Part 2: Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL (≥1000 cells/mm3); platelets ≥75 x 109/L (75 x 103/mm3). * Total bilirubin ≤3 x upper limit normal (ULN) * Serum albumin ≥3.0 g/dL unless prothrombin time is within the normal range Exclusion: * Prior radioembolization * Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II heart failure, left ventricular ejection fraction (LVEF) \<40% or QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 ms for males and \>470 ms for females. * Resistant hypertension, defined as uncontrolled blood pressure (BP) \>140/90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton et al. 2018) * Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8% * PRRT other than Lu-177 SSA (not applicable for ad hoc subcohort of the PK/ECG substudy) * Any condition requiring systemic treatment with high-dose glucocorticoids within 14 days prior to first dose of study treatment and/or which cannot be stopped while on study. Inhaled or topical steroids are permitted. * Prior history of liver cirrhosis or liver transplantation

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Research Facility Phoenix Arizona Active Not Recruiting
Research Facility Duarte California Completed
Research Facility Irvine California Recruiting
Research Facility Los Angeles California Active Not Recruiting
Research Facility Palo Alto California Active Not Recruiting
Research Facility San Francisco California Active Not Recruiting
Research Facility New Haven Connecticut Active Not Recruiting
Research Facility Washington D.C. District of Columbia Active Not Recruiting
Research Facility Jacksonville Florida Active Not Recruiting
Research Facility Miami Florida Recruiting
Research Facility Tampa Florida Recruiting
Research Facility Atlanta Georgia Active Not Recruiting
Research Facility Iowa City Iowa Recruiting
Research Facility Lexington Kentucky Recruiting
Research Facility Glen Burnie Maryland Recruiting
Research Facility Boston Massachusetts Active Not Recruiting
Research Facility Boston Massachusetts Active Not Recruiting
Research Facility Troy Michigan Completed
Research Facility Rochester Minnesota Active Not Recruiting
Research Facility St Louis Missouri Recruiting
Research Facility Omaha Nebraska Recruiting
Research Facility New York New York Active Not Recruiting
Research Facility New York New York Recruiting
Research Facility Cleveland Ohio Active Not Recruiting
Research Facility Columbus Ohio Recruiting
Research Facility Portland Oregon Active Not Recruiting
Research Facility Philadelphia Pennsylvania Active Not Recruiting
Research Facility Pittsburgh Pennsylvania Recruiting
Research Facility Nashville Tennessee Active Not Recruiting
Research Facility Houston Texas Active Not Recruiting
Research Facility Salt Lake City Utah Recruiting
Research Facility Seattle Washington Recruiting
Research Facility Brussels Belgium Recruiting
Research Facility Leuven Belgium Active Not Recruiting
Research Facility Roeselare Belgium Active Not Recruiting
Research Facility Brasília Brazil Active Not Recruiting
Research Facility Rio de Janeiro Brazil Completed
Research Facility São Paulo Brazil Active Not Recruiting
Research Facility London Ontario Active Not Recruiting
Research Facility Toronto Ontario Active Not Recruiting

+ 14 more sites — see the full list on the official registry below.

More RayzeBio, Inc. trials in Canada

Other trials for the same condition

Official registry record

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 Canada