USO 25017

A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER.(C5731006/SGNDV-006)

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Measurable disease per RECIST (bone only excluded)
• Local testing for ER/PR/HER2
• Prior PARPi required for BRCA mut and HER2-low/ultralow MBC
• No prior therapy with ADCs w/ MMAE payload
Cohort 1 HER2+ and HR+ or HR-: No more than 3 prior cytotoxics for MBC
• Rcvd prior THP as 1L tx; prior T-DXd for MBC required
• Prior tucatinib allowed
Cohort 2 HR+/ HER2-low: No more than 3 prior cytotoxics for MBC
• Prior T-DXd for MBC required
• ET refractory or intolerant to ET
• PD on >2L of ET for MBC and rcvd prior CDK4/6i for EBC or MBC OR PD on 1
prior line of ET for MBC and relapsed on adjuvant ET and rcvd prior CDK4/6i
for EBC or MBC
Cohort 3 HR+/ HER2-ultralow or HR-/HER2-low (HER2-lowTNBC)
• No more than 4 prior cytotoxics for MBC
• PD-L1+ TNBC must have rcvd pembro or PD-(L)1inhibitor + chemo
• HR+/HER2 ultralow must have rcvd at least 1 line of
ET; must have rcvd CDK 4/6i for EBC or MBC
• Prior SG and T-DXd allowed

For more information on this trial CLICK HERE .

Available at:

• Chesapeake
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)
• Williamsburg