Phase I Study Evaluating Safety and Effectiveness of 225AcAc-DOTATATE in Adults With Inoperable or Advanced Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the safety and efficacy of 225AcAc-DOTATATE in adults with inoperable, locally advanced or metastatic, progressive, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine neoplasms. This phase I study includes patients who are either new to peptide receptor radionuclide therapy PRRT or have previously received it. The study aims to find a suitable dose and understand the treatments tolerability. Participants receive 225AcAc-DOTATATE infusions every 8 weeks for up to four cycles. The dose escalation phase has two groups one with patients who had prior 177Lu-PRRT treatment and one without. Dose levels range from 90 kBqkg to 120 kBqkg per cycle. Following this, a dose expansion phase groups patients based on their Ki-67 index, a marker of tumor growth. During the study, participants undergo regular assessments including imaging to measure tumor sites, blood tests to monitor organ function and bone marrow capacity, and evaluations of symptoms and side effects. Researchers will measure safety and tolerability up to 32 weeks after the first infusion and determine the recommended dose within 56 days. Additionally, tumor response and disease progression will be tracked for up to 24 months after the last dose. Participants are monitored closely throughout to ensure safety and collect detailed data on treatment effects.

A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens