# Zelenectide pevedotin

Source: https://onco.cc/drugs/zelenectide-pevedotin/  
OnCo record `zelenectide-pevedotin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-07
- Tags: lesson:trial-design-registration
- 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.
- Dosing: Intravenous; 5 mg/m² weekly, 3 weeks on / 1 off (optimised dose), alone or with pembrolizumab

## Sources

- ClinicalTrials.gov: trials of Zelenectide pevedotin: https://clinicaltrials.gov/search?intr=BT8009

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Peptide-drug & small-molecule-drug conjugates](https://onco.cc/technologies/peptide-drug-conjugate/)
- targets: [Nectin-4](https://onco.cc/targets/nectin4/)
- companies: [Bicycle Therapeutics](https://onco.cc/companies/bicycle-therapeutics/)
- trials: [Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies](https://onco.cc/trials/nct04561362/), [Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)](https://onco.cc/trials/nct06225596/), [Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer](https://onco.cc/trials/nct06840483/), [Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer](https://onco.cc/trials/nct06933329/)

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