# Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Source: https://onco.cc/trials/nct04561362/  
OnCo record `nct04561362` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: 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
- Enrolled: 329

## Sources

- ClinicalTrials.gov NCT04561362: https://clinicaltrials.gov/study/NCT04561362

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Zelenectide pevedotin](https://onco.cc/drugs/zelenectide-pevedotin/)

---
JSON: https://onco.cc/api/v1/entities/nct04561362.json