{"entity":{"id":"fda018-adc","kind":"drug","name":"FDA018-ADC","aka":["FDA018-Antibody-drug Conjugate"],"tldr":"FDA018-ADC is an experimental antibody-drug conjugate from Shanghai Fudan-Zhangjiang Bio-Pharmaceutical in phase 3 trials for triple-negative breast cancer, with its target not yet stated publicly.","summary":"FDA018-ADC (FDA018) is an antibody-drug conjugate developed by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06519370 (FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer), in triple-negative breast cancer. The largest, NCT06519370, plans to enrol 350 participants with primary completion was scheduled for 2026-08-18 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of FDA018-ADC","url":"https://clinicaltrials.gov/search?intr=FDA018"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["fuscc"],"pathways":[],"terms":[],"trials":["nct06519370"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"FDA018","modality":"ADC","mechanism":"Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fda018-adc/","neighbours":{"cancer":[{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"institution":[{"id":"fuscc","kind":"institution","name":"Fudan University Shanghai Cancer Center","route":"/institutions/fuscc/"}],"trial":[{"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/"}]}}