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

NCT ID: NCT02391194

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-01-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVB-620

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

Group Type: EXPERIMENTAL

AVB-620

Intervention Type: DRUG

Interventions

AVB-620

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Avelas Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moores UC San Diego Cancer Center

La Jolla, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Stanford Hospitals and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

AVB620-C-001

Identifier Type: -

Identifier Source: org_study_id