Clinical trial · Interventional
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
NCT02391194CI-TRIAL-00026578completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVB-620 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AVB-620
- description
- Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.
- interventionNames
- Drug: AVB-620
Primary outcomes (1)
- measure
- Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
- timeFrame
- 30 days
- description
- 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 outcomes (1)
- measure
- Characterize the pharmacokinetic profile of AVB-620
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.