{"entity":{"id":"lu177-fap-vg11","kind":"drug","name":"177Lu-FAP-VG11","aka":["FAP-VG11","177Lu-FAP-VG11 Injection"],"tldr":"177Lu-FAP-VG11 is an experimental radioactive medicine from VitsGen Therapeutics that targets FAP, a protein on the support cells around many tumours. It is in an early hospital-led trial in China, and the FDA has given it orphan drug status for soft tissue sarcoma.","summary":"177Lu-FAP-VG11 is VitsGen Therapeutics' FAP-targeted radionuclide drug conjugate. The company reports higher FAP binding, tumour uptake, retention and tumour-to-kidney ratio than comparators in preclinical studies. China's NMPA accepted its IND application (acceptance number CXHL2600985) on 12 August 2026, and an early phase 1 investigator-initiated trial in FAP-positive advanced solid tumours, sponsored by Shandong Cancer Hospital and Institute, is registered as NCT07808177. On 22 October 2026 the FDA granted orphan drug designation for the treatment of soft tissue sarcoma.","asOf":"2026-11-04","links":[{"label":"VitsGen: orphan designation announcement","url":"https://www.vitsgen.com/News?article_id=151"},{"label":"ClinicalTrials.gov: NCT07808177","url":"https://clinicaltrials.gov/study/NCT07808177"},{"label":"FDA orphan designation record","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1153626"}],"tags":["pipeline","orphan-designation"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["lu177-radioligand-therapy"],"targets":["fap"],"drugs":[],"companies":["vitsgen-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"code":"177Lu-FAP-VG11","modality":"Lutetium-177 radioligand","mechanism":"A ligand that binds fibroblast activation protein (FAP), carried by fibroblasts in the tumour microenvironment, chelated to lutetium-177, whose beta particles damage DNA in the targeted cells and in neighbouring tumour cells (the crossfire effect), as the developer describes it.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-10-22","type":"designation","region":"US","note":"FDA orphan drug designation for soft tissue sarcoma, granted to VitsGen Therapeutics","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1153626","indication":"treatment of soft tissue sarcoma"}]},"route":"/drugs/lu177-fap-vg11/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"lu177-radioligand-therapy","kind":"technology","name":"Lutetium-177 radioligand therapy","route":"/technologies/lu177-radioligand-therapy/"}],"target":[{"id":"fap","kind":"target","name":"FAP","route":"/targets/fap/"}],"company":[{"id":"vitsgen-therapeutics","kind":"company","name":"VitsGen Therapeutics","route":"/companies/vitsgen-therapeutics/"}]}}