Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
NCT ID: NCT05477576
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
288 participants
INTERVENTIONAL
2022-03-24
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b - RYZ101
Part 1 is an uncontrolled dose de-escalation study to confirm the safety and determine the RP3D of RYZ101 based on Bayesian optimal interval design.
RYZ101
RP3D as determined in Phase 1b
Phase 3 - RYZ101
Actinium 225 radiolabeled somatostatin analog (SSA) for injection
RYZ101
RP3D as determined in Phase 1b
Phase 3 - Standard of Care
Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Everolimus
Everolimus
Sunitinib
Sunitinib
Octreotide
High-dose octreotide
Lanreotide
Lanreotide
Phase 3 - RYZ101, PK/ECG Substudy adhoc subcohort
Actinium 225 radiolabeled somatostatin analog (SSA) for injection
RYZ101
RP3D as determined in Phase 1b
Interventions
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RYZ101
RP3D as determined in Phase 1b
Everolimus
Everolimus
Sunitinib
Sunitinib
Octreotide
High-dose octreotide
Lanreotide
Lanreotide
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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RayzeBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ye Yuan, MD
Role: STUDY_DIRECTOR
RayzeBio Sr. Medical Director
Locations
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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
Research Facility
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
Research Facility
Boston, Massachusetts, United States
Research Facility
Boston, Massachusetts, United States
Research Facility
Troy, Michigan, United States
Research Facility
Rochester, Minnesota, United States
Research Facility
St Louis, Missouri, United States
Research Facility
Omaha, Nebraska, United States
Research Facility
New York, New York, United States
Research Facility
New York, New York, United States
Research Facility
Cleveland, Ohio, United States
Research Facility
Columbus, Ohio, United States
Research Facility
Portland, Oregon, United States
Research Facility
Philadelphia, Pennsylvania, United States
Research Facility
Pittsburgh, Pennsylvania, United States
Research Facility
Nashville, Tennessee, United States
Research Facility
Houston, Texas, United States
Research Facility
Salt Lake City, Utah, United States
Research Facility
Seattle, Washington, United States
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, Canada
Research Facility
Toronto, Ontario, Canada
Research Facility
Montreal, Quebec, Canada
Research Facility
Clichy, , France
Research Facility
Lille, , France
Research Facility
Montpellier, , France
Research Facility
Nantes, , France
Research Facility
Vandœuvre-lès-Nancy, , France
Research Facility
Villejuif, , France
Research Facility
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
Countries
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Central Contacts
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Facility Contacts
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References
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Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.
Other Identifiers
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RYZ101-301
Identifier Type: -
Identifier Source: org_study_id
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