{"entity":{"id":"jskn016","kind":"drug","name":"JSKN016","aka":[],"tldr":"JSKN016 is an experimental drug that targets two proteins on cancer cells and carries chemotherapy. It has reached phase 3 testing; earlier response findings do not prove comparative benefit.","summary":"JSKN016 targets TROP2 and HER3. SABCS 2025 abstract PS1-09-05 reports an uncontrolled phase I breast cohort at the September 5, 2025 cutoff: 82 enrolled patients, including 50 with TNBC and 32 with HR-positive/HER2-negative disease. Among 47 efficacy-evaluable TNBC patients, ORR was 57.4% by investigators and 63.8% by independent review. Median follow-up was 5.0 months. Grade 3 neutropenia occurred in 4.9% of the breast cohort; no interstitial lung disease was reported in that abstract. NCT07533123 separately registers phase 3 testing in previously treated TNBC. Its highest registered phase is not the evidence level of the phase I response estimate.","status":"phase-3","asOf":"2026-10-06","links":[{"label":"Publisher abstract","url":"https://doi.org/10.1158/1557-3265.sabcs25-ps1-09-05"},{"label":"Publisher abstract","url":"https://doi.org/10.1200/jco.2025.43.16_suppl.e13138"},{"label":"ClinicalTrials.gov NCT06592417","url":"https://clinicaltrials.gov/study/NCT06592417"},{"label":"ClinicalTrials.gov NCT07533123","url":"https://clinicaltrials.gov/study/NCT07533123"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","breast-hr-positive"],"sections":[],"technologies":["adc","bispecific-adc"],"targets":["trop2","her3"],"drugs":[],"companies":["alphamab"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07533123","nct06942234","nct06592417"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"ADC","payload":"TOP1 inhibitor, DAR 4","mechanism":"Bispecific anti-TROP2/HER3 antibody-drug conjugate with a cleavable linker and a TOP1 inhibitor payload.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/jskn016/","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/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"bispecific-adc","kind":"technology","name":"Bispecific ADC","route":"/technologies/bispecific-adc/"}],"target":[{"id":"her3","kind":"target","name":"HER3","route":"/targets/her3/"},{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"alphamab","kind":"company","name":"Alphamab Oncology","route":"/companies/alphamab/"}],"trial":[{"id":"nct07533123","kind":"trial","name":"A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care","route":"/trials/nct07533123/"},{"id":"nct06775483","kind":"trial","name":"Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study","route":"/trials/nct06775483/"},{"id":"nct06942234","kind":"trial","name":"Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer","route":"/trials/nct06942234/"},{"id":"nct06592417","kind":"trial","name":"To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors","route":"/trials/nct06592417/"}]}}