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

• ClinicalTrials.gov Identifier: NCT02391194
• Recruitment Status: Completed
• First Posted: March 18, 2015
• Last Update Posted: March 22, 2017
• Sponsor: Avelas Biosciences, Inc.
• Information provided by (Responsible Party): Avelas Biosciences, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: AVB-620	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
• Study Start Date: April 2015
• Actual Primary Completion Date: January 2017
• Actual Study Completion Date: January 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: AVB-620; Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.	Drug: AVB-620

Outcome Measures

Primary Outcome Measures :

1. Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values [ Time Frame: 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 Outcome Measures :

1. Characterize the pharmacokinetic profile of AVB-620 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Moores UC San Diego Cancer Center

La Jolla, California, United States, 92093

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94115

Stanford Hospitals and Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Avelas Biosciences, Inc.

More Information

• Responsible Party: Avelas Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT02391194
• Other Study ID Numbers: AVB620-C-001
• First Posted: March 18, 2015
• Last Update Posted: March 22, 2017
• Last Verified: March 2017

Keywords provided by Avelas Biosciences, Inc.:

AVB-620; stage I; newly diagnosed; breast cancer; stage II; stage III; ductal carcinoma in situ

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases