{"entity":{"id":"fap-2286","kind":"drug","name":"FAP-2286 (177Lu / 68Ga)","aka":[],"tldr":"A FAP-targeted theranostic pair: one version images almost any solid tumour, the other treats it with radiation.","summary":"FAP-2286 is a theranostic pair: a cyclic peptide that binds fibroblast activation protein (FAP), linked to a DOTA chelator carrying 68Ga for PET imaging or 177Lu for beta therapy. FAP sits on cancer-associated fibroblasts in the stroma of most solid tumours rather than on cancer cells, so one agent can image and irradiate many tumour types, and the cyclic peptide gives longer tumour retention than the FAPI small molecules used for imaging. Clovis Oncology developed it until its 2022 bankruptcy; Novartis then acquired it via 3B Pharmaceuticals. The 177Lu-FAP-2286 LuMIERE phase 1/2 trial is dose-escalating in cycles every 6 weeks with pancreatic, sarcoma and breast cohorts. For a newcomer: a radioligand aimed at the scaffolding around tumours rather than the tumour cells.","status":"phase-2","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov: trials of FAP-2286 (177Lu / 68Ga)","url":"https://clinicaltrials.gov/search?intr=FAP-2286"}],"tags":[],"related":[],"cancers":["pancreatic","sarcoma","tnbc"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":["fap"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05939414","nct06520345","nct07219238","nct05413850","nct06894511","nct05142696","nct04939610"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"FAP-2286","modality":"Theranostic pair (peptide radioligand)","mechanism":"Cyclic peptide FAP binder with DOTA chelator for 68Ga (imaging) or 177Lu (therapy).","approvals":[],"mechanismSteps":["Radioligand circulates and binds FAP on cancer-associated fibroblasts on tumour cells","Ligand is internalised or retained at the membrane","Beta emissions deposit energy within a short range","Clustered DNA double-strand breaks form in the tumour cell and its neighbours (crossfire)","Cells die; unbound ligand is cleared via the kidneys"],"dosing":{"route":"IV infusion (177Lu) or injection (68Ga)","schedule":"LuMIERE phase 1/2 dose escalation, cycles every 6 weeks","monitoring":"Blood counts, renal function","source":"https://clinicaltrials.gov/study/NCT04939610"},"toxicity":[{"event":"Anaemia"},{"event":"Thrombocytopenia"},{"event":"Fatigue"},{"event":"Nausea"}],"access":[{"country":"US","reimbursement":"Investigational","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-01","type":"filing","region":"US","note":"Novartis acquires rights after Clovis bankruptcy","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/fap-2286/","neighbours":{"cancer":[{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"fapi-pet","kind":"technology","name":"FAPI PET","route":"/technologies/fapi-pet/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"target":[{"id":"fap","kind":"target","name":"FAP","route":"/targets/fap/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"trial":[{"id":"nct05142696","kind":"trial","name":"A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab","route":"/trials/nct05142696/"},{"id":"nct04939610","kind":"trial","name":"A Study of 177Lu-FAP-2286 in Advanced Solid Tumors","route":"/trials/nct04939610/"},{"id":"nct05939414","kind":"trial","name":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.","route":"/trials/nct05939414/"},{"id":"nct06894511","kind":"trial","name":"An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC","route":"/trials/nct06894511/"},{"id":"nct05413850","kind":"trial","name":"Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","route":"/trials/nct05413850/"},{"id":"nct07219238","kind":"trial","name":"Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, o","route":"/trials/nct07219238/"},{"id":"nct06520345","kind":"trial","name":"The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)","route":"/trials/nct06520345/"}],"roadmap":[{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","route":"/roadmaps/radiopharma-roadmap/"}],"idea":[{"id":"idea-fap-theranostics-pancancer","kind":"idea","name":"FAP theranostics as a pan-cancer stromal strategy","route":"/ideas/idea-fap-theranostics-pancancer/"}],"person":[{"id":"uwe-haberkorn","kind":"person","name":"Uwe Haberkorn","route":"/people/uwe-haberkorn/"}],"bottleneck":[{"id":"b-tme-immunosuppression","kind":"bottleneck","name":"Cold tumours and the immunosuppressive microenvironment","route":"/bottlenecks/b-tme-immunosuppression/"}],"institution":[{"id":"uk-duesseldorf","kind":"institution","name":"University Hospital Düsseldorf / CIO Düsseldorf","route":"/institutions/uk-duesseldorf/"}],"pathway":[{"id":"caf-activation-desmoplasia","kind":"pathway","name":"Fibroblast activation, desmoplasia & matrix stiffness","route":"/pathways/caf-activation-desmoplasia/"},{"id":"invasion-ecm-degradation","kind":"pathway","name":"Invasion: proteases, adhesion & the invasive front","route":"/pathways/invasion-ecm-degradation/"}]}}