Zelenectide Pevedotin for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop any systemic anticancer therapy at least 28 days before starting the study treatment. Additionally, you cannot take medications that strongly affect certain liver enzymes (CYP3A) or P-glycoprotein while on the study.
What data supports the effectiveness of the drug Zelenectide Pevedotin for breast cancer?
What is the purpose of this trial?
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 Criteria
This trial is for people with advanced breast cancer that has come back or spread and can't be removed by surgery. Participants must have a life expectancy of at least 12 weeks, be relatively active (able to care for themselves), and have measurable disease. They need confirmed NECTIN4 gene amplification and should have received some prior therapy but not too much: up to 3 treatments if their cancer grows despite hormone therapy, or between 1-3 treatments if they have triple-negative breast cancer.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zelenectide pevedotin for NECTIN4-amplified advanced breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Zelenectide Pevedotin
Find a Clinic Near You
Who Is Running the Clinical Trial?
BicycleTx Limited
Lead Sponsor