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

StatusActive, Not Recruiting
PhasePhase 1
Started2024-10-08
View on ClinicalTrials.gov ↗
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.

Amendment history 1 change detected by DataLookout

2026-09-04
Enrollment closed, study ongoing
Trial Details
NCT Number NCT06617169
Lead Sponsor Monopar Therapeutics
Conditions Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Ovarian Cancer +1 more
Enrollment 12 participants
Start Date 2024-10-08
Primary Completion 2027-01 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-03