Monopar Therapeutics Initiates Phase 1a Trial of uPAR-Targeted Radiopharmaceutical MNPR-101-Lu in Advanced Cancers

Key Insights

• Monopar Therapeutics has commenced a Phase 1a clinical trial for MNPR-101-Lu, a novel radiopharmaceutical targeting urokinase plasminogen activator receptor (uPAR) in advanced solid tumors.
• The open-label, dose-escalation study will initially enroll patients already participating in the MNPR-101-Zr imaging trial to identify those most likely to benefit from the therapy.
• MNPR-101-Lu aims to selectively target and kill cancer cells expressing uPAR, which is found in various tumor types, while minimizing damage to healthy tissue.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced the initiation of a Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu, designed to target the urokinase plasminogen activator receptor (uPAR) in patients with advanced cancers. The trial is currently active and recruiting patients.

The Phase 1a trial is an open-label, dose-escalation study evaluating the safety and preliminary efficacy of MNPR-101-Lu in patients with advanced solid tumors. The first clinical trial site activated is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To ensure patient selection enriches for likely responders, the trial will initially enroll participants from the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial (NCT06337084).

Targeting uPAR with Radiopharmaceutical Therapy

MNPR-101 is Monopar’s proprietary antibody that selectively binds to uPAR, a receptor overexpressed in several cancer types, including pancreatic, breast, colorectal, ovarian, and bladder cancers. By conjugating MNPR-101 with lutetium-177 (Lu-177), a radioactive isotope, Monopar aims to deliver targeted radiation directly to cancer cells, inducing cell death while sparing healthy tissues. Preclinical data and early clinical data from the MNPR-101-Zr imaging trial have demonstrated specific and durable tumor uptake.

Management Perspectives

"We are very encouraged by the recently released human clinical data and preclinical efficacy results and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

Andrew Cittadine, Monopar’s Chief Operating Officer, added, "We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial. Our goal is to light up the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu."

Trial Details

The MNPR-101-Lu trial (NCT06617169) is designed as a dose-escalation study to determine the optimal dose and safety profile of the radiopharmaceutical. Further information about the trial is available at www.ClinicalTrials.gov.