Phase 1a Study Testing Increasing Doses of MNPR-101-PCTA-177Lu Given by IV to Treat Solid Tumor Cancers

What this Trial Is About

Researchers are evaluating the safety and dosing of MNPR-101-PCTA-177Lu, a radioactive drug, in adults with solid tumor cancers who previously participated in a related imaging study. This Phase 1a, open-label, multi-center study focuses on increasing doses gradually to find safe levels while monitoring side effects and treatment impact. The study uses a special method called TITE-BOIN to decide dose changes based on patient responses. Participants will receive three intravenous infusions of MNPR-101-PCTA-177Lu over 20 minutes each, given on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, with doses ranging from 480 to 2240 MBq depending on dose level. The treatment cycles last 12 weeks, and dosing decisions for patient groups of two are made using dose escalation or de-escalation rules. Imaging and scans such as SPECT and CT are performed at specific time points to assess the drugs effect on tumors. During the study, patients will have blood tests and imaging to monitor safety, side effects, and tumor response, with a follow-up period of 12 weeks after the last dose. Researchers will track dose-limiting toxicities, adverse events, and radiologic response rates using established criteria. The total study duration covers initial dosing, treatment cycles, and safety monitoring to evaluate the drugs safety profile and appropriate dosing levels.

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors