Multicenter Phase I Study of Triapine in Combination with [177Lu]Lutetium-Dotatate in Patients with Well-Differentiated Neuroendocrine Tumors (ETCTN 10388)

The next generation of theranostics studies is looking at novel combinations with radiation sensitizers to enhance peptide receptor radionuclide therapy's efficacy. In this study, we present safety and efficacy data from a multicenter phase I study of a [177Lu]lutetium-dotatate-triapine combination in patients with gastroenteropancreatic (GEP) neuroendocrine tumors (NET).

The study consisted of 2 phases (part A: dose escalation; part B: dose expansion) administering the recommended phase II doses (RP2D) for the 2 agents. All patients received 200 mCi of [177Lu]lutetium-dotatate on day 1 of four 8-week cycles, in combination with oral triapine administered at assigned dose levels (100, 150, or 200 mg) from day 1 to day 14 of each cycle.