Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
This is a Phase I clinical trial to assess the safety and dosimetry profiles of 177Lu-DOTA-EB-TATE in patients with advanced, metastatic or inoperable, somatostatin receptor-positive, well-differentiated GEP-NETs.
• 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.
• Either no prior treatment with 177Lu-DOTA-TATE or at least 12 months progression-free survival (PFS) after prior treatment with 177Lu-DOTA-TATE