drugset / Trial / NCT06617169

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

NCT06617169 ↗

Phase 1 Recruiting 12 enrolled Monopar Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, uncontrolled, multi-center, phase 1a MNPR-101-PCTA-177Lu dose-escalation study in patients with solid tumor cancers. Patients must have participated in the imaging study MNPR-101-D001 (actively recruiting, diagnostic study of MNPR-101-DFO\*-89Zr). * TITE-BOIN will be used to objectively determine dose increase, no dose change, or dose decrease for each group of two patients. * The treatment period consists of two 12-week cycles. Patients will receive three equal fractions of MNPR-101-PCTA-177Lu with radioactivity ranging from 480-2240 MBq on each of Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (12 weeks after Cycle 1 Day 1). * Patients will be followed for 12 weeks after their last dose of MNPR-101-PCTA-177Lu. * Patients will be imaged at specific timepoints during the study.

Timeline

Start
2024-10-08
Primary completion
2026-12
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject MNPR-101-PCTA-177Lu Monoclonal antibody 480 mbq Intravenous
Subject MNPR-101-PCTA-177Lu Monoclonal antibody 960 mbq Intravenous
Subject MNPR-101-PCTA-177Lu Monoclonal antibody 1440 mbq Intravenous
Subject MNPR-101-PCTA-177Lu Monoclonal antibody 1920 mbq Intravenous
Subject MNPR-101-PCTA-177Lu Monoclonal antibody 2240 mbq Intravenous