Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Zelenectide pevedotin (BT8009): Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Study 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).
Eligibility
Primary outcome measure(s)
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator — Up to approximately 3 years
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) | Baltimore | Maryland | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| Siteman Cancer Center | St Louis | Missouri | |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York | New York | |
| Duke Cancer Institute | Durham | North Carolina | |
| Compass Oncology - Rose Quarter Cancer Center | Portland | Oregon | |
| Texas Oncology San Antonio | San Antonio | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | |
| UZ Leuven | Leuven | Belgium | |
| Oncopole Claudius Regaud | Toulouse | France | |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST | Meldola | Forli/Cesena | |
| Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche | Ancona | Italy | |
| Istituto Europeo di Oncologia | Milan | Italy | |
| Hospital Quironsalud Barcelona | Barcelona | Spain | |
| Hospital Beata Maria Ana | Madrid | Spain | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| The Royal Marsden NHS Foundation Trust | London | United Kingdom |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06840483 on ClinicalTrials.gov ↗ ← All trials in France