Study on RYZ101 Compared to Standard Treatment for Inoperable Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) After Previous Therapy

Sponsor: RayzeBio, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05477576

Provider View

This clinical trial is testing a new drug, RYZ101, to see if it is safe and effective for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) that cannot be removed by surgery and have worsened after previous treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called RYZ101 for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) that cannot be operated on and have progressed after receiving a specific type of therapy known as 177Lu-SSA. The study will compare RYZ101 to the standard treatments currently chosen by doctors for these patients. The study is divided into two parts: the first part will focus on finding the safest dose of RYZ101, while the second part will compare its effectiveness and safety to standard treatments.

Eligibility 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

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.