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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
RECRUITINGYale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGSibley Memorial Hospital
Washington D.C., District of Columbia, United States
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Time frame: Up to approximately 3 years
Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)
Safety and tolerability will be reported as incidence, severity, seriousness, relationship, and type of treatment-emergent adverse events, abnormalities in laboratory, electrocardiogram (ECG), vital signs and treatment modifications using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
Time frame: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator
DoR as measured by the time from first documentation of objective response to the first documentation of disease progression assessed by the Investigator or to death (due to any cause), whichever occurs first.
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
Percentage of participants with confirmed CR, PR, or stable disease (SD)
Time frame: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator
Percentage of participants with CR, PR or SD ≥16 weeks
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator
PFS is measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression per RECIST v1.1 as assessed by the Investigator, or to death (due to any cause), whichever occurs first.
Time frame: Up to approximately 3 years
Overall Survival
OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
Time frame: Up to approximately 4 years
Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator
TTP is defined as the time from first dose of study drug administration until first documentation of disease progression.
Time frame: Up to approximately 4 years
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGSiteman Cancer Center
St Louis, Missouri, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITING...and 29 more locations