Breast Cancer
Conditions
Keywords
AVB-620, stage I, newly diagnosed, breast cancer, stage II, stage III, ductal carcinoma in situ
Brief summary
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
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.
Interventions
DRUGAVB-620
Sponsors
Avelas Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the pharmacokinetic profile of AVB-620 | 8 days | 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. |
Countries
United States
Outcome results
None listed