Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with specific types of neuroendocrine tumors, particularly gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The study is comparing a novel therapy called 161Tb-DOTA-LM3, which uses a radioactive substance to target tumors, to the current standard treatment, 177Lu-DOTATOC. The goal is to see how effective and safe the new treatment is when compared to the existing one. The trial will involve a small group of participants, with each person receiving both treatments in a specific order.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with advanced GEP-NETs that cannot be surgically removed. They should have measurable tumors and must not have had certain recent treatments or conditions that could interfere with the study. Patients will receive injections in two phases, followed by additional treatment cycles, and they will be closely monitored throughout the study. This trial is currently recruiting participants, and it’s a chance for patients to explore a promising new treatment option while helping advance medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written consent
• • Patients with diagnosed and metastasized secreting and non-secreting GEP-NEN (grade 1 and 2)
• • Absence of a curative surgical option
• • At least 2 measurable tumours based on RECIST 1.1 (minimal tumour diameter of 1 cm)
• • Documentation of a positive 68Ga-DOTATOC/-TATE positron emission tomography (PET)/CT (in vivo detection of SST2 on GEP-NENs)
• • Indication for PRRT
• • Patient of any gender and of age older than 18
• • Female patients of child-bearing age (who are not surgically sterilized or are less than 2 years in their menopause) must use a medically accepted contraceptive and must agree to use it during and till 3 months after the treatment. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)
• • Eastern Cooperative Oncology Group (ECOG) ≤ 2
• * Blood parameters:
• • h) Leucocytes ≥ 3\*109/L i) Haemoglobin ≥ 90 g/L j) Thrombocytes ≥ 90\*109/L k) Estimated glomerular filtration rate ≥ 50 ml/min or Creatinine \< 150 μmol/l l) Albumin \> 25 g/L m) alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value n) Bilirubin ≤ 2 times upper standard value
• Exclusion Criteria:
• • Known intolerance against 177Lu, 161Tb, DOTA, TOC, LM3, SST analogues or against one of the components of 177Lu-DOTATOC or 161Tb-DOTA-LM3
• • Bone/bone marrow metastases located in the lumbar spine if they affect the bone marrow dose estimation
• • Ongoing infection at the screening visit or a serious infection in the past 4 weeks
• • Administration of another investigational product in the last 60 days before Visit 1 Day 1
• • Prior or planed administration of a therapeutic radio-pharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
• • Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study
• • Chemotherapy in the last 4 weeks before inclusion
• • Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child-bearing age.
• • Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \[HbA1c ≥ 9%\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.