RecruitingPhase 1NCT06617169

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

Open Label, Phase 1a, Dose-Escalation Study Evaluating the Safety of Fractionated MNPR-101-PCTA-177Lu Dosing in the Treatment of Solid Tumor Cancers

Sponsor

Monopar Therapeutics

Enrollment

12 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer Colorectal, Cancer Pancreatic Cancer Gastric Cancer Ovarian Cancer Urothelial Carcinoma Lung Cancer Solid Tumor, Adult Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a radioactive drug called MNPR-101-PCTA-177Lu, which is designed to target and destroy solid tumors. It is a dose-escalation study, meaning researchers are gradually increasing the dose to find the highest safe and effective amount. This trial is only open to people who already participated in a related earlier study (MNPR-101-D001). **You may be eligible if...** - You previously participated in the MNPR-101-D001 study - If you could become pregnant, you had a negative pregnancy test at screening - You agree to use effective contraception during and for 3 months after the study - If breastfeeding, you agree to stop before dosing and for 3 months after **You may NOT be eligible if...** - You have received other chemotherapy or radiation recently (timing restrictions apply) - You did not participate in the earlier MNPR-101-D001 study - You are unable to meet contraception or breastfeeding requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMNPR-101-PCTA-177Lu

MNPR-101-PCTA-177Lu administered intravenously over approximately 20 minutes, followed by a normal saline flush. Dosing will occur on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1.

Locations(1)

Melbourne Theranostic Innovation Centre (MTIC)

North Melbourne, Victoria, Australia

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