← Back to Search

Antibody-drug conjugate

Zelenectide Pevedotin for Breast Cancer

Nashville, TN
Phase 2
Recruiting
Research Sponsored by BicycleTx Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
* Eastern Cooperative Oncology Group Performance Status of ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test the effectiveness and safety of a drug called zelenectide pevedotin in patients with a specific type of advanced breast cancer. There will be two groups of participants:

See full description
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing Zelenectide pevedotin on two groups of patients with advanced breast cancer: those whose tumors grow despite hormone therapy (HR+/HER2-) and those with triple-negative breast cancer. It's an open-label study, meaning everyone knows what treatment they're getting, aiming to see how effective and safe this new drug is.See study design
What are the potential side effects?
While the specific side effects of Zelenectide pevedotin are not listed here, similar drugs often cause symptoms like fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling in hands and feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a confirmed NECTIN4 gene change.
 show original
Select...
I can do most of my daily activities on my own.
 show original
Select...
I have TNBC or ER-low positive breast cancer and received 1-3 treatments for advanced disease.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by Investigator
Secondary study objectives
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (TNBC)Experimental Treatment1 Intervention
Group II: Cohort A (HR+/HER2-negative breast cancer)Experimental Treatment1 Intervention

Find a Location

Closest Location:SCRI Oncology Partners· Nashville, TN· 620 miles

Who is running the clinical trial?

BicycleTx LimitedLead Sponsor
4 Previous Clinical Trials
1,773 Total Patients Enrolled
~44 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top