Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.

Detailed Description
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This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.

Official Title
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A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: AVB-620


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate renal function Lab values (hematology and chemistry) within institution's normal laboratory limits Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon) If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits Subject has the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Recurrent ipsilateral breast cancer Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery. Open surgery in the ipsilateral breast within 1 year of AVB-620 administration History of radiation therapy to ipsilateral breast Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration Diagnosis of autoimmune disorders History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded History of renal disease or current evidence of renal disease Current diagnosis of any other active or clinically significant non-breast cancer Systemic investigational drug of any kind within 6 weeks of AVB-620 administration Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVB-620<br>Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure. | Drug: AVB-620<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values | The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacokinetic profile of AVB-620 | The pharmacokinetics (PK) of AVB-620 will be characterized by collecting and reviewing individual subject plasma concentrations and primary parameters, including clearance, Cmax, Cmin, and distribution. | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVB-620, stage I, newly diagnosed, breast cancer, stage II, stage III, ductal carcinoma in situ