{"entity":{"id":"zelenectide-pevedotin","kind":"drug","name":"Zelenectide pevedotin","aka":[],"tldr":"A tiny peptide instead of an antibody carries the same payload as Padcev to Nectin-4, with far less rash and neuropathy in early data, but its developer stepped back in 2026.","summary":"Duravelo-2 (randomised phase 2/3): encouraging responses and a differentiated safety profile (skin reactions ~4-fold lower, neuropathy half that of enfortumab vedotin), presented ASCO 2026. Bicycle Therapeutics deprioritised the programme in March 2026 after regulators indicated the trial design could not support registration.","status":"phase-2","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov: trials of Zelenectide pevedotin","url":"https://clinicaltrials.gov/search?intr=BT8009"}],"tags":["lesson:trial-design-registration"],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["peptide-drug-conjugate"],"targets":["nectin4"],"drugs":[],"companies":["bicycle-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06933329","nct06840483","nct06225596","nct04561362"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"BT8009","modality":"Bicycle toxin conjugate (Nectin-4, MMAE)","mechanism":"Bicyclic peptide binds Nectin-4; cleavable linker releases MMAE; rapid renal clearance limits systemic exposure.","approvals":[],"mechanismSteps":["Bicyclic peptide binds Nectin-4 with high affinity","Short plasma half-life; tumour penetration within hours","Cleavable linker releases MMAE inside the tumour","Bystander killing with less skin and nerve exposure than antibody ADCs"],"dosing":{"route":"Intravenous","schedule":"5 mg/m² weekly, 3 weeks on / 1 off (optimised dose), alone or with pembrolizumab"},"toxicity":[{"event":"Fatigue","anyGradePct":40},{"event":"Skin reactions","anyGradePct":13,"note":"Roughly one quarter the rate reported for enfortumab vedotin"},{"event":"Peripheral neuropathy","anyGradePct":25}],"access":[],"regulatoryEvents":[{"date":"2026-03","type":"withdrawal","region":"US","note":"Programme deprioritised after regulatory feedback on Duravelo-2 design","source":"https://www.oncologypipeline.com/apexonco/bicycle-finally-falls"}]},"route":"/drugs/zelenectide-pevedotin/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"peptide-drug-conjugate","kind":"technology","name":"Peptide-drug & small-molecule-drug conjugates","route":"/technologies/peptide-drug-conjugate/"}],"target":[{"id":"nectin4","kind":"target","name":"Nectin-4","route":"/targets/nectin4/"}],"company":[{"id":"bicycle-therapeutics","kind":"company","name":"Bicycle Therapeutics","route":"/companies/bicycle-therapeutics/"}],"trial":[{"id":"nct04561362","kind":"trial","name":"Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies","route":"/trials/nct04561362/"},{"id":"nct06225596","kind":"trial","name":"Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)","route":"/trials/nct06225596/"},{"id":"nct06840483","kind":"trial","name":"Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer","route":"/trials/nct06840483/"},{"id":"nct06933329","kind":"trial","name":"Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer","route":"/trials/nct06933329/"}]}}