{"entity":{"id":"esg401","kind":"drug","name":"ESG401","aka":[],"tldr":"ESG401 is an experimental drug that delivers chemotherapy to cells bearing TROP2. Early breast-cancer response results are being followed by larger trials.","summary":"ASCO 2025 abstract 1044 reports 156 patients enrolled in ESG401-101 at the October 23, 2024 cutoff. Distinct efficacy populations included 37 late-line TNBC patients (ORR 35.1%, 95% CI 20.2 to 52.5) and 35 first-line TNBC patients (ORR 83.0%, 95% CI 66.4 to 93.4). These nonrandomized cohorts have different lines of treatment and cannot be pooled or compared directly with phase 3 ADC trials. Grade 3 or higher treatment-related events were mainly neutropenia and leukopenia. The phase 1/2 NCT04892342 is completed; later registered phase 3 development is separate from this early evidence.","status":"phase-3","asOf":"2026-10-06","links":[{"label":"Publisher abstract","url":"https://doi.org/10.1200/jco.2025.43.16_suppl.1044"},{"label":"ClinicalTrials.gov NCT04892342","url":"https://clinicaltrials.gov/study/NCT04892342"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","breast-hr-positive"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":[],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06732323","nct06383767","nct04892342"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"ADC","payload":"SN-38 (TOP1 inhibitor)","mechanism":"Humanized anti-TROP2 IgG1 conjugated to SN-38 through a stable cleavable linker.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/esg401/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"qilu-pharmaceutical","kind":"company","name":"Qilu Pharmaceutical","route":"/companies/qilu-pharmaceutical/"}],"trial":[{"id":"nct06383767","kind":"trial","name":"A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer","route":"/trials/nct06383767/"},{"id":"nct06732323","kind":"trial","name":"A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer","route":"/trials/nct06732323/"},{"id":"nct04892342","kind":"trial","name":"Study of ESG401 in Adults With Solid Tumors","route":"/trials/nct04892342/"}]}}