Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets.
Neil K Taunk, Freddy E Escorcia, Jason S Lewis...
https://pubmed.ncbi.nlm.nih.gov/38753757Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05477576
Phase 1b/3 Global, Randomized, Controlled Trial Comparing RYZ101 to Standard of Care in Advanced SSTR+ GEP-NETs After Prior 177Lu-SSA Therapy
Led by RayzeBio, Inc. · Updated on 2026-03-30
338
Participants Needed
54
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying RYZ101, a drug being evaluated for safety, pharmacokinetics (PK), and the recommended Phase 3 dose in patients with inoperable, advanced, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that express somatostatin receptors (SSTR+). These tumors have progressed after treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapies such as 177Lu-DOTATATE or 177Lu-DOTATOC. The study aims to compare RYZ101 with standard care therapies in these patients to better understand treatment options for this condition. The trial includes two parts: Part 1 is an uncontrolled dose de-escalation study to confirm safety and determine the recommended Phase 3 dose of RYZ101 using a Bayesian optimal interval design. Part 2 is a randomized, open-label comparison of RYZ101 against standard of care therapies, which include everolimus, sunitinib, octreotide, or lanreotide. RYZ101 is an Actinium 225 radiolabeled somatostatin analog administered by injection. The study evaluates the drug's safety, efficacy, and pharmacokinetics compared to these established treatments. Participants will be monitored through various assessments including imaging to confirm tumor progression and somatostatin receptor expression, laboratory tests to check kidney and blood function, and safety evaluations. The primary outcomes include determining the recommended Phase 3 dose in Part 1 over 56 days of treatment and progression-free survival in Part 3 after sufficient events occur. The total duration and follow-up vary by participant, with safety and efficacy data collected throughout the study. The trial is sponsored by RayzeBio, Inc. and plans to continue until December 2030.
CONDITIONS
Brief Title
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed Grade 1-2 well-differentiated, inoperable, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with Ki67 index ≤20% (except for PK/ECG substudy ad hoc subcohort)
- Progressive, somatostatin receptor (SSTR)-positive GEP-NETs after 2-4 cycles of 177Lu-labeled somatostatin analogue therapy with disease control for at least 6 months
- At least one measurable site of disease positive on SSTR-PET imaging and no measurable metastatic lesions negative on SSTR imaging
- Adequate kidney function with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2
- Adequate blood function including hemoglobin ≥5.0 mmol/L (8.0 g/dL), absolute neutrophil count ≥1000 cells/μL, platelets ≥75 x 10^9/L
- Total bilirubin ≤3 times upper limit of normal
- Serum albumin ≥3.0 g/dL unless prothrombin time is normal
You will not qualify if you...
- Prior radioembolization treatment
- Significant cardiovascular disease such as NYHA Class II or higher heart failure, left ventricular ejection fraction below 40%, or prolonged QT interval above 450 ms for males and 470 ms for females
- Resistant hypertension uncontrolled by at least three antihypertensive medications including a diuretic
- Uncontrolled diabetes mellitus with hemoglobin A1C of 8% or higher
- Prior peptide receptor radionuclide therapy (PRRT) other than Lutetium 177-labelled SSA (not applicable to PK/ECG substudy ad hoc subcohort)
- Use of high-dose systemic glucocorticoids within 14 days before study treatment or inability to stop such treatment during the study (inhaled or topical steroids allowed)
- History of liver cirrhosis or liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 56 days of study treatment in Phase 1b; longer treatment duration not specified for Phase 3
Participants receive RYZ101 or standard of care treatment including everolimus, sunitinib, octreotide, or lanreotide as assigned.
Visit schedule varies depending on treatment assignment
Trial Site Locations
Total: 54 locations
1
Research Facility
Phoenix, Arizona, United States, 85054
Active, Not Recruiting
2
Research Facility
Duarte, California, United States, 91010
Completed
3
Research Facility
Irvine, California, United States, 92663
Actively Recruiting
4
Research Facility
Los Angeles, California, United States, 90095
Active, Not Recruiting
5
Research Facility
Palo Alto, California, United States, 94305
Active, Not Recruiting
6
Research Facility
San Francisco, California, United States, 94143
Active, Not Recruiting
7
Research Facility
New Haven, Connecticut, United States, 06510
Active, Not Recruiting
8
Research Facility
Washington D.C., District of Columbia, United States, 20010
Active, Not Recruiting
9
Research Facility
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
10
Research Facility
Miami, Florida, United States, 33165
Actively Recruiting
11
Research Facility
Tampa, Florida, United States, 33607
Actively Recruiting
12
Research Facility
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
13
Research Facility
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
Research Facility
Lexington, Kentucky, United States, 40536
Actively Recruiting
15
Research Facility
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
16
Research Facility
Boston, Massachusetts, United States, 02118
Active, Not Recruiting
17
Research Facility
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
18
Research Facility
Troy, Michigan, United States, 48098
Completed
19
Research Facility
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
20
Research Facility
St Louis, Missouri, United States, 63110
Actively Recruiting
21
Research Facility
Omaha, Nebraska, United States, 68130
Actively Recruiting
22
Research Facility
New York, New York, United States, 10029
Active, Not Recruiting
23
Research Facility
New York, New York, United States, 10065
Actively Recruiting
24
Research Facility
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
25
Research Facility
Columbus, Ohio, United States, 43221
Actively Recruiting
26
Research Facility
Portland, Oregon, United States, 97239
Active, Not Recruiting
27
Research Facility
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
28
Research Facility
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
29
Research Facility
Nashville, Tennessee, United States, 37232
Active, Not Recruiting
30
Research Facility
Houston, Texas, United States, 77030
Active, Not Recruiting
31
Research Facility
Salt Lake City, Utah, United States, 84112
Actively Recruiting
32
Research Facility
Seattle, Washington, United States, 98109
Actively Recruiting
33
Research Facility
Brussels, Belgium
Actively Recruiting
34
Research Facility
Leuven, Belgium
Active, Not Recruiting
35
Research Facility
Roeselare, Belgium
Active, Not Recruiting
36
Research Facility
Brasília, Brazil
Active, Not Recruiting
37
Research Facility
Rio de Janeiro, Brazil
Completed
38
Research Facility
São Paulo, Brazil
Active, Not Recruiting
39
Research Facility
London, Ontario, Canada
Active, Not Recruiting
40
Research Facility
Toronto, Ontario, Canada, M4N 3M5
Active, Not Recruiting
41
Research Facility
Montreal, Quebec, Canada
Active, Not Recruiting
42
Research Facility
Clichy, France
Actively Recruiting
43
Research Facility
Lille, France
Actively Recruiting
44
Research Facility
Montpellier, France
Active, Not Recruiting
45
Research Facility
Nantes, France
Active, Not Recruiting
46
Research Facility
Vandœuvre-lès-Nancy, France
Actively Recruiting
47
Research Facility
Villejuif, France
Active, Not Recruiting
48
Research Facility
Amsterdam, Netherlands
Actively Recruiting
49
Research Facility
Maastricht, Netherlands
Active, Not Recruiting
50
Research Facility
Utrecht, Netherlands
Actively Recruiting
51
Research Facility
Seoul, South Korea
Active, Not Recruiting
52
Research Facility
Barcelona, Spain
Actively Recruiting
53
Research Facility
Madrid, Spain
Actively Recruiting
54
Research Facility
Zaragoza, Spain
Completed
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Research Team
R
RayzeBio Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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