SHS_492468 BUCC CAVB 19040

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Inclusion Criteria:

DCIS or Stage I-III primary invasive carcinoma of the breast
Primary surgical treatment is lumpectomy + SLNB or ALND --or-- mastectomy + ALND
Signed written informed consent
At least 18 years of age
ECOG performance status 0 to 2
Life expectancy of at least 6 months
Total bilirubin ≤ 2 mg/dL
AST/SGOT and ALT/SGPT ≤ 2.5 X ULN
Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
LVEF within normal limits if patient received prior anthracycline therapy [Period 1].
Exclusion Criteria:

Recurrent ipsilateral breast cancer
Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
Open surgery in ipsilateral breast within 1 year.
Prior malignancy, other than breast cancer, active within the last 6 months
Prior radiation therapy to the chest [Period 2]
Radiation therapy to ipsilateral breast [Period 1]
Abnormal cardiac rhythm not controlled with medication; Hx of stroke within 1 year; Hx of coronary events and/or heart failure within 1 year.
Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
Hx of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids.
Hx of drug-induced acute tubular necrosis.
Chronic renal failure or current evidence of moderate to severe renal impairment.
Current diagnosis of any other active or clinically significant nonbreast cancer
Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously.
Pregnant or breast feeding or plans to become pregnant within 6 months of AVB-620 administration.
Unresolved acute toxicity from prior anticancer therapy
Phase II
NCT03113825
Cancer
Breast
Claire Buchanan, M.D., FACS
Avelas Biosciences, Inc.
Renae Koepke
  • Swedish Medical Center