DV-006 is a Phase 1b/2, open-label, multicohort study of disitamab vedotin (DV) in adults with locally advanced, unresectable, or metastatic HER2-expressing breast cancer who have progressed on or after prior treatments.
Participants with the following types of breast cancer may be eligible:
- Cohort 1: HR-negative/HER2-positive and HR-positive/HER2-positive
- Cohort 2: HR-positive/HER2-low
- Cohort 3: HR-negative/HER2-low (HER2-low TNBC) and HR-positive/HER2-ultralow
Arms and Interventions
Population and HER2 Status
LA/mBC;
- Cohort 1: HER2-positive (IHC 3+ or IHC2+ and ISH+),
- Cohort 2: HR-positive/HER2-low (IHC 2+ ISH negative or IHC 1+),
- Cohort 3: HR-positive/HER2-ultralow (IHC 0 with membrane staining) or HER2–low, HR negative (triple negative) mBC
Open-Label Study Treatment
Disitamab vedotin monotherapy
Inclusion Criteria
This is not a complete list of inclusion and exclusion criteria. Please connect with a Principal Investigator for further information
Prior therapy requirements
- Cohorts 1 (HER2+, HR+ or HR- participants:
- No more than 3 prior lines of cytotoxic therapy
- Progression on, after, or intolerant to T-DXd in any line advanced disease setting
- Cohort 2 (HR+/HER2-low participants):
- No more than 3 prior lines of cytotoxic therapy
- Progression on, after, or intolerant to T-DXd in any line advanced disease setting
- Must have intolerance to endocrine therapy (ET) or ET refractory disease
- Cohorts 3 (HR+/HER2-ultralow or HR-/HER2-low [HER2 low TNBC] participants):
- No more than 4 prior lines of cytotoxic therapy
- Prior T-DXd or sacituzumab govitecan is allowed
HER2 and HR status appropriate for enrollment in cohort
- HER+: IHC 3+ or IHC 2+/ISH+
- HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH negative
- HER2-ultralow: IHC 0 with membrane staining (any staining of the membrane in >0 and ≤10% of cancer cells)
Historically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic breast carcinoma
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Measurable disease per RECIST v1.1
Exclusion Criteria
Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin
History of other invasive malignancy within 3 years before study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Prior therapy with ADCs with MMAE payload
Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks to first dose of study treatment
Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.
- CNS metastases have been clinically stable for at least 4 weeks without evidence of new or worsening CNS metastasis
- Participant is on a stable or decreasing dose of ≤10 mg/day of prednisone or equivalent
- Participant does not have leptomeningeal metastasis.
Outcomes
Primary outcomes
- Objective response (OR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Secondary outcomes
- Duration of response (DOR) per RECIST v1.1 by investigator assessment
- Disease control rate (DCR) per RECIST v1.1 by investigator assessment
- Progression free survival (PFS) per RECIST v1.1 by investigator assessment
- Overall survival (OS)
- Estimate of selected Pharmacokinetic (PK) parameter of disitamab vedotin, total antibody, and unconjugated MMAE
- Incidence of anti-drug antibodies (ADAs) against disitamab vedotin
- Safety (type, incidence, severity, seriousness, and relatedness of adverse events [AEs])
Get started
Answer a 2-minute questionnaire and speak to a study representative.
A first step as you consider connecting with a Principal Investigator is to answer a 2-minute online questionnaire about your interest and willingness to be contacted. If your answers show the study might be a good fit for you and your patient, you may choose to have your contact information shared with a study clinic that you select for further discussion.
Get connected.
Your answers to these questions will only be linked to you if your responses indicate that you would like to be connected with a Principal Investigator and you choose to share your contact information with the study clinic. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if your patient meets the study’s eligibility criteria and is able to enroll in the study.