{"entity":{"id":"fda018-adc","kind":"drug","name":"FDA018-ADC","aka":["F0024","FDA018-Antibody-drug Conjugate"],"tldr":"FDA018-ADC, also called F0024, is an experimental drug that carries chemotherapy to TROP2-bearing cells. Early response results do not establish a benefit over standard treatment.","summary":"NCT05174637 identifies F0024 as an alternative name for FDA018-ADC. ASCO 2024 abstract e13131 reports 62 treated patients at the October 8, 2023 cutoff. At 10 mg/kg, 11/29 efficacy-evaluable TNBC patients had partial responses (ORR 37.9%, 95% CI 20.7 to 57.7). Grade 3 or higher treatment-related adverse events occurred in 32/62 patients (51.6%), including grade 3 neutropenia in 45.2%. The selected dose cohort is not a randomized efficacy comparison. Later phase 3 registration is separate from this first-in-human evidence.","status":"phase-3","asOf":"2026-10-06","links":[{"label":"Publisher abstract","url":"https://doi.org/10.1200/jco.2024.42.16_suppl.e13131"},{"label":"ClinicalTrials.gov NCT05174637","url":"https://clinicaltrials.gov/study/NCT05174637"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":[],"companies":[],"institutions":["fuscc"],"pathways":[],"terms":[],"trials":["nct06519370","nct05174637"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"FDA018","modality":"ADC","payload":"SN-38 (TOP1 inhibitor)","mechanism":"TROP2-directed ADC delivering SN-38, the active metabolite of irinotecan.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fda018-adc/","neighbours":{"cancer":[{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"institution":[{"id":"fuscc","kind":"institution","name":"Fudan University Shanghai Cancer Center","route":"/institutions/fuscc/"}],"trial":[{"id":"nct05174637","kind":"trial","name":"A Study of FDA018-ADC in Patients With Advanced Solid Tumors","route":"/trials/nct05174637/"},{"id":"nct06519370","kind":"trial","name":"FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","route":"/trials/nct06519370/"}]}}