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RECRUITING

NCT05477576

PHASE3

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

Sponsor: RayzeBio, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2022-03-24

Completion Date

2030-12

Last Updated

2026-03-30

Healthy Volunteers

Conditions

GEP-NET Gastroenteropancreatic Neuroendocrine Tumor Gastroenteropancreatic Neuroendocrine Tumor Disease Neuroendocrine Tumors Carcinoid Carcinoid Tumor Pancreatic NET

Interventions

DRUG

RYZ101

RP3D as determined in Phase 1b

DRUG

Everolimus

DRUG

Sunitinib

DRUG

Octreotide

High-dose octreotide

DRUG

Lanreotide

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

Locations (54)

Research Facility

Phoenix, Arizona, United States

Research Facility

Duarte, California, United States

Research Facility

Irvine, California, United States

Research Facility

Los Angeles, California, United States

Research Facility

Palo Alto, California, United States

Research Facility

San Francisco, California, United States

Research Facility

New Haven, Connecticut, United States

Research Facility

Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

Research Facility

Miami, Florida, United States

Research Facility

Tampa, Florida, United States

Research Facility

Atlanta, Georgia, United States

Research Facility

Iowa City, Iowa, United States

Research Facility

Lexington, Kentucky, United States

Research Facility

Glen Burnie, Maryland, United States

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Boston, Massachusetts, United States

Research Facility

Boston, Massachusetts, United States

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Troy, Michigan, United States

Research Facility

Rochester, Minnesota, United States

Research Facility

St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New York, New York, United States

Research Facility

New York, New York, United States

Research Facility

Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

Research Facility

Houston, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Brussels, Belgium

Research Facility

Leuven, Belgium

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Roeselare, Belgium

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Brasília, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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London, Ontario, Canada

Research Facility

Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Clichy, France

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Lille, France

Research Facility

Montpellier, France

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Nantes, France

Research Facility

Vandœuvre-lès-Nancy, France

Research Facility

Villejuif, France

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Amsterdam, Netherlands

Research Facility

Maastricht, Netherlands

Research Facility

Utrecht, Netherlands

Research Facility

Seoul, South Korea

Research Facility

Barcelona, Spain

Research Facility

Madrid, Spain

Research Facility

Zaragoza, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)