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NCT05477576 | RECRUITING | GEP-NET

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.

Brief 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.

Condition or disease

Pasted-not

Gastroenteropancreatic Neuroendocrine Tumor

Gastroenteropancreatic Neuroendocrine Tumor Disease

Neuroendocrine Tumors

Carcinoid

Carcinoid Tumor

Pancreatic NET

Intervention/treatment

RYZ101

Everolimus

Sunitinib

Octreotide

Lanreotide

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 288 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-03-24
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2028-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion
  • * 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
  • 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
    • * 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
Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Location Details

NCT05477576

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Research Facility

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

Research Facility

Duarte, California, United States, 91010

RECRUITING

United States, California

Research Facility

Irvine, California, United States, 92663

RECRUITING

United States, California

Research Facility

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Research Facility

Palo Alto, California, United States, 94305

RECRUITING

United States, California

Research Facility

San Francisco, California, United States, 94143

RECRUITING

United States, Connecticut

Research Facility

New Haven, Connecticut, United States, 06510

RECRUITING

United States, District of Columbia

Research Facility

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

Research Facility

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Florida

Research Facility

Miami, Florida, United States, 33165

RECRUITING

United States, Florida

Research Facility

Tampa, Florida, United States, 33607

RECRUITING

United States, Georgia

Research Facility

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Iowa

Research Facility

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Kentucky

Research Facility

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Maryland

Research Facility

Glen Burnie, Maryland, United States, 21061

RECRUITING

United States, Massachusetts

Research Facility

Boston, Massachusetts, United States, 02118

RECRUITING

United States, Massachusetts

Research Facility

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Research Facility

Troy, Road cancer, United States, 48098

RECRUITING

United States, Minnesota

Research Facility

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Research Facility

St. Louis, Missouri, United States, 63110

RECRUITING

United States, Nebraska

Research Facility

Omaha, Nebraska, United States, 68130

RECRUITING

United States, New York

Research Facility

New York, New York, United States, 10029

RECRUITING

United States, New York

Research Facility

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Research Facility

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Oregon

Research Facility

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Research Facility

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

Research Facility

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Tennessee

Research Facility

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Texas

Research Facility

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Research Facility

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Washington

Research Facility

Seattle, Washington, United States, 98109

RECRUITING

Belgium,

Research Facility

Brussels, Belgium,

ACTIVE NOT RECRUITING

Belgium,

Research Facility

Brussel, Belgium,

NOT YET RECRUITING

Belgium,

Research Facility

Leuven, Belgium,

RECRUITING

Belgium,

Research Facility

Roeselare, Belgium,

RECRUITING

Brazil,

Research Facility

Brasilia, Brazil,

NOT YET RECRUITING

Brazil,

Research Facility

Rio de Janeiro, Brazil,

RECRUITING

Brazil,

Research Facility

São Paulo, Brazil,

RECRUITING

Canada, Ontario

Research Facility

London, Ontario, Canada,

RECRUITING

Canada, Ontario

Research Facility

Toronto, Ontario, Canada, M4N 3M5

NOT YET RECRUITING

Canada, Quebec

Research Facility

Montréal, Quebec, Canada,

NOT YET RECRUITING

France,

Research Facility

Clichy, France,

NOT YET RECRUITING

France,

Research Facility

Lille, France,

RECRUITING

France,

Research Facility

Nantes, France,

NOT YET RECRUITING

France,

Research Facility

Vandoeuvre-lès-Nancy, France,

NOT YET RECRUITING

France,

Research Facility

Villejuif, France,

RECRUITING

Korea, Republic of,

Research Facility

Seoul, Korea, Republic of,

RECRUITING

Netherlands,

Research Facility

Utrecht, Netherlands,

NOT YET RECRUITING

Spain,

Research Facility

Barcelona, Spain,

NOT YET RECRUITING

Spain,

Research Facility

Madrid, Spain,

NOT YET RECRUITING

Spain,

Research Facility

Zaragoza, Spain,