On August 14, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, reported the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr (Press release, Monopar Therapeutics, AUG 14, 2024, View Source [SID1234645924]).

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MNPR-101-Zr was well-tolerated with no serious adverse reactions reported through the last imaging timepoint and the corresponding initial safety review. Preliminary analysis of MNPR-101-Zr’s pharmacokinetics and biodistribution suggests the low radiation dose to healthy tissue aligns with what was anticipated based on the previously presented MNPR-101-Zr preclinical biodistribution data. Dosimetry analysis showed absorbed organ doses were well below accepted safety limits; for example, the radiation dose to red bone marrow was about 14 mGy, which is around 150 times less than the generally accepted limit of 2-to-3 Gy. No unanticipated or excessive uptake of MNPR-101-Zr was observed in any critical organs through the end of the subject’s imaging period. The patient has metastatic disease from a cancer type not known for high uPAR expression. The study aims to include several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression.

"The safety profile observed thus far, along with the encouraging biodistribution data, gives us an increased confidence as we continue to advance our Phase 1 study and prepare to launch our therapeutic study," said Andrew Cittadine, Monopar’s Chief Operating Officer.

Further information about the ongoing MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.