A Study of U3-1402 (Patritumab Deruxtecan) in Subjects with Metastatic Breast Cancer
- Conditions
- Metastatic Breast CancerLocally Advanced Breast Cancer
- Interventions
- Drug: U3-1402
- Registration Number
- NCT04699630
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
- Detailed Description
U3-1402 (Patritumab Deruxtecan) is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This is a phase II study of U3-1402 (patritumab deruxtecan) in subjects with MBC. The study will be conducted in 3 parts (Part A , Part B, and Part Z). All enrolled subjects in Part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER/PR/HER2/HER3) show preliminary efficacy. Part B will enroll subgroups of participants that are metastatic, hormone receptor-positive (HR+) HER2-negative or triple-negative (mTNBC) regardless of HER3 expression that were defined from Part A analysis. Part Z will enroll participants with HER2- positive (HER2+) MBC.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B U3-1402 Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression. Part A U3-1402 Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 participants will be enrolled into this arm. Part Z U3-1402 Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months. ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) (i.e., confirmation at least 4 weeks apart) according to RECIST Version 1.1 criteria.
Per RECIST V1.1: A CR is defined as disappearance of all target and non-target lesions. A PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline sum.Rate of participants without disease progression at 6 month to determine six-months Progression Free survival (PFS-6) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC Every 6 weeks after day 1 for the first 6 months PFS-6 is defined as the rate of participants without disease progression (PD) at six months from the start of study drug according to RECIST version 1.1 criteria.
Per RECIST V1.1, a PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions
- Secondary Outcome Measures
Name Time Method Median Progression-Free Survival (PFS) in participants with MBC Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of the first documented disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause.
Per RECIST V1.1, a PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesionsIncidence of participants with adverse events to assess the safety and tolerability of U3-1402 (patritumab deruxtecan) in participants with MBC From day 1 until 40 days after end of treatment or up to 33 months Safety is determined by proportion of participants who experience adverse events and serious adverse events when given U3-1402.
Overall response rate (ORR) of single agent U3-1402 (patritumab deruxtecan) in participants with HER2+ MBC after progression on trastuzumab deruxtecan Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months ORR is defined as the rate of participants with confirmed complete response (CR) or partial response (PR) (i.e., confirmation at least 4 weeks apart) according to RECIST Version 1.1 criteria.
Per RECIST V1.1: A CR is defined as disappearance of all target and non-target lesions. A PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline sum.Median Duration of Response (DOR) in participants with MBC Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months. Duration of response (DOR) is defined as the duration from the first documented response to the date of disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause.
Per RECIST V1.1, a PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesionsClinical Benefit Rate (CBR) in participants with MBC Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months CBR is defined as the rate of participants with CR, PR, or best overall response of SD for ≥ 6 months according to the RECIST v 1.1 criteria Per RECIST V1.1: A CR is defined as the disappearance of all target and non-target lesions. A PR is defined as ≥30% decrease in the sum of diameters of target lesions from the baseline sum. An SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Rate of participants without disease progression at 6 month to determine six-months Progression Free survival (PFS-6) of single agent U3-1402 (patritumab deruxtecan) in participants with HER2+ MBC after progression on trastuzumab deruxtecan Every 6 weeks after day 1 for the first 6 months PFS-6 is defined as the rate of participants without disease progression (PD) at six months from the start of study drug according to RECIST version 1.1 criteria.
Per RECIST V1.1, a PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions
Trial Locations
- Locations (11)
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
City of Hope
🇺🇸Duarte, California, United States
Florida Cancer Specialists-South
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists-North
🇺🇸St Petersburg, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Rutgers-Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
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