Actively Recruiting
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Led by RayzeBio, Inc. · Updated on 2026-03-30
338
Participants Needed
54
Research Sites
453 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs with Ki67 60% and ECOG status 0-2
- Progressive, SSTR-PET positive GEP-NET (gastrointestinal or pancreas) after 2-4 cycles of 177Lu-labeled SSA treatment
- Disease control for at least 6 months following Lutetium-177 SSA therapy
- At least one measurable disease site positive by SSTR-PET imaging and no measurable metastatic lesions negative by SSTR imaging
- Adequate renal function with estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2
- Adequate hematologic function with hemoglobin 65.0 mmol/L (8.0 g/dL), ANC 61000 cells/�b5L, platelets 675 x 10 9/L
- Total bilirubin 63 times upper limit normal
- Serum albumin 63.0 g/dL unless prothrombin time is normal
You will not qualify if you...
- Prior radioembolization treatment
- Significant cardiovascular disease including NYHA Class 65II heart failure, LVEF <40%, or QTcF >450 ms (males) or >470 ms (females)
- Resistant hypertension uncontrolled by optimal doses of at least 3 antihypertensive drugs including a diuretic
- Uncontrolled diabetes mellitus with hemoglobin A1C 68%
- Prior peptide receptor radionuclide therapy (PRRT) other than Lutetium-177 SSA
- Requirement for systemic high-dose glucocorticoids within 14 days before study treatment or inability to stop such treatment
- History of liver cirrhosis or liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
R
RayzeBio Clinical Trials
CONTACT
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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