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
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2
• 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. 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
Locations
United States
Arizona
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RECRUITING
Phoenix
California
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WITHDRAWN
Duarte
Research Facility
RECRUITING
Irvine
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Los Angeles
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Palo Alto
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San Francisco
Connecticut
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New Haven
Washington, D.c.
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Washington D.c.
Florida
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Jacksonville
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Miami
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Tampa
Georgia
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Atlanta
Iowa
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Iowa City
Kentucky
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Lexington
Massachusetts
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Boston
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Boston
Maryland
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Glen Burnie
Michigan
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WITHDRAWN
Troy
Minnesota
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RECRUITING
Rochester
Missouri
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St Louis
Nebraska
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Omaha
New York
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New York
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New York
Ohio
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Cleveland
Oregon
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Portland
Pennsylvania
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Philadelphia
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Pittsburgh
Tennessee
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Nashville
Texas
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Houston
Utah
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Salt Lake City
Washington
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Seattle
Other Locations
Belgium
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RECRUITING
Brussels
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Leuven
Research Facility
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Roeselare
Brazil
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Brasília
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Rio De Janeiro
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São Paulo
Canada
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London
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Montreal
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Toronto
France
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Clichy
Research Facility
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Lille
Research Facility
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Montpellier
Research Facility
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Nantes
Research Facility
RECRUITING
Vandœuvre-lès-nancy
Research Facility
RECRUITING
Villejuif
Netherlands
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RECRUITING
Amsterdam
Research Facility
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Maastricht
Research Facility
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Utrecht
Republic of Korea
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Seoul
Spain
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Barcelona
Research Facility
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Madrid
Research Facility
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Zaragoza
Contact Information
Primary
RayzeBio Clinical Trials
clinicaltrials@rayzebio.com
+1 619 657 0057
Time Frame
Start Date:2022-03-24
Estimated Completion Date:2028-07
Participants
Target number of participants:288
Treatments
Experimental: 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.
Active_comparator: Phase 3 - RYZ101
Actinium 225 radiolabeled somatostatin analog (SSA) for injection
Active_comparator: Phase 3 - Standard of Care
Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.