{"entity":{"id":"nct04639219","kind":"trial","name":"A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations","aka":[],"tldr":"A phase 2 trial of Trastuzumab deruxtecan in melanoma, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations is a phase 2 interventional study registered as NCT04639219 by AstraZeneca, with 102 participants enrolled, started 2020-12-30 and due to reach its primary completion in 2023-01-25. Interventions recorded: Trastuzumab deruxtecan. Conditions listed: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04639219","url":"https://clinicaltrials.gov/study/NCT04639219"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04639219-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04639219","phase":"2","setting":"A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology","sponsor":"AstraZeneca","started":"2020-12-30","startedType":"actual","yearReported":2024,"enrolled":102,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)","primary":true,"unit":"%","arms":[{"name":"T-DXd","n":102,"value":29.4,"note":"95% CI 20.8 to 39.3; Figures from the ClinicalTrials.gov results section (first posted 2024-02-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04639219?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"T-DXd","n":102,"value":10.9,"note":"95% CI 8.3 to 14.9; Figures from the ClinicalTrials.gov results section (first posted 2024-02-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04639219?tab=results"}]},"route":"/trials/nct04639219/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct04639219-lancet-oncol-2024","kind":"paper","name":"Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study","route":"/key-papers/paper-nct04639219-lancet-oncol-2024/"}]}}