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

Avelas Biosciences

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: AVB-620

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391194

AVB620-C-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

AVB-620

Experimental group

Description:

Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.

Treatment:

Drug: AVB-620