Monopar Initiates Clinical Trial of Novel uPAR-Targeted Radiopharmaceutical Therapy in Advanced Cancers


Monopar Therapeutics Inc. recently announced the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers. The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial.

MNPR-101 is Monopar’s proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical (link) and preclinical (link) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101-Zr (MNPR-101 conjugated to zirconium-89).

“We are very encouraged by the recently released human clinical data and preclinical efficacy results (link), 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.

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

Further information about the MNPR-101-Lu trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Details about the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial are available at www.ClinicalTrials.gov under study identifier NCT06337084.

Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development-stage radiopharma programs against solid cancers. For more information, visit www.monopartx.com.