NCT06840483

Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: BicycleTx Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Zelenectide pevedotin (BT8009)	Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Timeline

• Start date: 2025-03-03
• Primary completion: 2028-06-30
• Completion: 2028-12-30
• First posted: 2025-02-21
• Last updated: 2026-04-15

Locations

18 sites across 7 countries: United States, Australia, Belgium, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study