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Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Status
Active
Cancer Type
Neuroendocrine Tumor
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05477576
Protocol IDs
RYZ101-301 (primary)
NCI-2022-06406
Study Sponsor
RayzeBio, Inc.

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

  1. 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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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