First-in-Korea Clinical Trial of Lu-177-DOTATATE in Patients with Inoperable, Progressive Somatostatin Receptor-Positive, Metastatic or Locally Advanced Neuroendocrine Tumor (SNU-KB-01)

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Introduction: Peptide receptor radionuclide therapy (PRRT) based on Lu-177 DOTATATE is currently used worldwide as a treatment option for neuroendocrine tumor patients. But until now, no PRRT has been approved by the Korea Food and Drug Administration (KFDA). Thus, neuroendocrine tumor patients in Korea have severely limited access to the treatment. To provide treatment opportunities, we have planned a First-in-Korea phase I clinical trial of SNU-KB-01, no-carrier added Lu-177 labeled DOTATATE.

Aim(s): To determine the recommended phase 2 dose through the evaluation of safety/tolerability, dosimetry and exploratory efficacy of SNU-KB-01 in patients with inoperable, progressive somatostatin receptor-positive, metastatic or locally advanced neuroendocrine tumor.

Materials and methods: Main eligibility criteria: >18, <80 years; metastatic or locally advanced neuroendocrine tumors who are unable to undergo radical resection and have progressed during the conventional treatment; positive somatostatin receptor scan; Ki67 index ≤ 20%; Karnofsky performance score ≥ 50. We have not limited the indication to the gastro-entero-pancreatic (GEP) neuroendocrine tumors but included neuroendocrine tumor patients with positive somatostatin receptor scan. We applied rolling-6 method and set up two dose groups (150 mCi and 200 mCi). We designed the administration cycle as 4 time at 8-week intervals.

Conference: 17th Annual ENETSConcerence (2020)

Presenting Author:

Authors: Suh M, Cheon G, Lee D,

Keywords: PRRT, clinical trial, Neuroendocrine tumor, Lu-177-DOTATATE,