{"entity":{"id":"nct04561362","kind":"trial","name":"Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies","aka":[],"tldr":"A phase 1/2 trial of Zelenectide pevedotin and Pembrolizumab in bladder & urothelial cancer, triple-negative breast cancer, HR-positive / HER2-negative breast cancer, HER2-positive breast cancer, non-small-cell lung cancer and ovarian cancer, run by BicycleTx Limited, active and no longer recruiting.","summary":"Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies is a phase 1/2 interventional study registered as NCT04561362 by BicycleTx Limited, with 329 participants enrolled, started 2020-07-17 and due to reach its primary completion in 2026-03. Interventions recorded: BT8009 and Pembrolizumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04561362","url":"https://clinicaltrials.gov/study/NCT04561362"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","tnbc","breast-hr-positive","breast-her2-positive","nsclc","ovarian"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":[],"drugs":["zelenectide-pevedotin","pembrolizumab"],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04561362-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04561362","phase":"1/2","setting":"Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies","sponsor":"BicycleTx Limited","started":"2020-07-17","startedType":"actual","enrolled":329,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04561362/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"peptide-drug-conjugate","kind":"technology","name":"Peptide-drug & small-molecule-drug conjugates","route":"/technologies/peptide-drug-conjugate/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"zelenectide-pevedotin","kind":"drug","name":"Zelenectide pevedotin","route":"/drugs/zelenectide-pevedotin/"}],"company":[{"id":"bicycle-therapeutics","kind":"company","name":"Bicycle Therapeutics","route":"/companies/bicycle-therapeutics/"}],"paper":[{"id":"paper-nct04561362-j-clin-oncol-2025","kind":"paper","name":"First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation","route":"/key-papers/paper-nct04561362-j-clin-oncol-2025/"}]}}