{"entity":{"id":"mnpr-101","kind":"drug","name":"MNPR-101","aka":[],"tldr":"MNPR-101 is an experimental radiolabelled humanised monoclonal antibody from Monopar Therapeutics, in phase 1 trials for advanced solid tumours expressing uPAR, bladder/urothelial cancer and triple-negative breast cancer and other cancers.","summary":"MNPR-101 is a radiolabelled humanised monoclonal antibody (imaging with zirconium-89; therapy with lutetium-177, actinium-225 preclinical) from Monopar Therapeutics. A humanised antibody against the urokinase plasminogen activator receptor (uPAR); labelled with zirconium-89 it is a PET imaging agent, and labelled with lutetium-177 (or actinium-225, preclinical) it delivers radiation to uPAR-expressing tumours. Its furthest stage is phase 1, for advanced solid tumours expressing uPAR, bladder/urothelial cancer, triple-negative breast cancer and lung cancer. ClinicalTrials.gov registers it in 2 studies linked below. 10-K for 2025 (filed 27 March 2026): MNPR-101-Zr phase 1 imaging/dosimetry, MNPR-101-Lu phase 1a, MNPR-101-Ac late preclinical; FDA IND for MNPR-101-Lu cleared 26 September 2025. Registry: NCT06337084 and NCT06617169 active, not recruiting; expanded-access programmes NCT06980506 and NCT06980519 temporarily not available. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Monopar Therapeutics: monopartx.com","url":"https://www.monopartx.com"},{"label":"Monopar Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926010025/mnpr20251231_10k.htm"},{"label":"Monopar Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT06617169"},{"label":"ClinicalTrials.gov: trials of MNPR-101","url":"https://clinicaltrials.gov/search?intr=MNPR-101"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","urothelial","tnbc","lung-cancer","colorectal","gastric","ovarian","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["monopar"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06337084","nct06617169"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"MNPR-101","modality":"Radiolabelled humanised monoclonal antibody (imaging with zirconium-89; therapy with lutetium-177, actinium-225 preclinical)","mechanism":"A humanised antibody against the urokinase plasminogen activator receptor (uPAR); labelled with zirconium-89 it is a PET imaging agent, and labelled with lutetium-177 (or actinium-225, preclinical) it delivers radiation to uPAR-expressing tumours.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mnpr-101/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"company":[{"id":"monopar","kind":"company","name":"Monopar Therapeutics","route":"/companies/monopar/"}],"trial":[{"id":"nct06337084","kind":"trial","name":"Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors","route":"/trials/nct06337084/"},{"id":"nct06617169","kind":"trial","name":"Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors","route":"/trials/nct06617169/"}]}}