Ability to understand and willing to sign a written informed consent document. Aged 18 years or older. Histologically proven or cytologically confirmed, inoperable, GEP-NETs. Neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to World Health Organization
(WHO) 2017 classification. Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1. Overexpression of somatostatin receptors of the target lesions in 68Ga-DOTA-TATE positron
emission tomography (PET)/computed tomography (CT) with SUV of lesions greater than normal
liver in at least 1 lesion. A Cockcroft Gault calculated creatinine clearance > 60 mL/min. Karnofsky performance status scale ≥ 70%
Women of childbearing potential and men must agree to use adequate contraception prior to
study entry and for the duration of study participation, including follow-up (7 months
after the last dose of study drug for women and 4 months for men).
Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if
completed >4 weeks prior to study entry.
Previous surgery no less than 6 weeks prior to study entry.
Women who are pregnant or breastfeeding. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to 177Lu-DOTA-EB-TATE as assessed from medical records. Previous treatment with 177Lu-DOTA-TATE. Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or
treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever
is longer, before the first administration of study drug.
Participant has not fully recovered from major surgery or significant traumatic injury
prior the first dose of study drug or expects to have major surgery during the study period
or within 3 months after the last dose of study drug.
Life expectancy < 6 months as assessed by the treating physician. > 80% liver involvement by tumor. > 25% bone marrow involvement by tumor. Poorly differentiated neuroendocrine neoplasms, such as poorly differentiated
neuroendocrine carcinoma, small- and large-cell neuroendocrine carcinoma; mixed
neuroendocrine-non-neuroendocrine neoplasm (MiNEN); Grade 3 neuroendocrine carcinomas (NEC)
Presence of somatostatin receptor negative lesions if they cannot be addressed with
loco-regional therapies prior to the treatment start. Deteriorated renal function, as indicated by a serum creatinine clearance > 1.7 mg/dL. Deteriorated bone marrow function. Deteriorated liver function. Toxicities from prior therapies that have not resolved to grade 1 or grade 0. Active and clinically significant bacterial, fungal, or viral infection, including
hepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), or acquired
immunodeficiency syndrome (AIDS)-related illness. Known brain metastases and/or carcinomatous meningitis, unless these metastases have been
treated and stabilized. Uncontrolled diabetes mellitus as defined by a HbA1c >9%
Impossibility to interrupt short-acting octreotide for 24 h before and 24 h after the
administration of 177Lu-DOTA-EB-TATE; impossibility to have an interval of ≥4 weeks between
octreotide and 177Lu-DOTA-EB-TATE. The use of somatostatin and its analogues within 4 months of a planned 177Lu-DOTA-EB-TATE
treatment. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements. Prior external beam radiation therapy involving >25% of the bone marrow. Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe. Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ
of the uterine cervix, unless definitively treated and with no evidence of recurrence