AVB-620 has completed a Phase Ib clinical trial in women undergoing breast cancer surgery (NCT02391194) and is currently being investigated in a Phase II/II clinical trial for fluorescent detection of cancer during breast cancer surgery (NCT03113825).

Phase 1 Trial of AVB-620 in women with Primary, Non-Recurrent Breast Cancer Undergoing Surgery (NCT02391194

Avelas’ first-in-human Phase 1 study examined the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. A total of 27 women received AVB-620 during this two-part, multi-institutional trial. No adverse events or laboratory values attributable to infusion of AVB-620 were found. By the time of surgery, there were measurable differences between tumor-positive and tumor-negative tissue allowing for separation between them based on fluorescence imaging analysis.

Data from this clinical trial has been published in the Annals of Surgical Oncology in a paper titled “Intraoperative Tumor Detection Using a Ratiometric Activatable Fluorescent Peptide: A First-in-Human Phase I Study” (link).

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women with Primary, Nonrecurrent Breast Cancer Undergoing Surgery (NCT03113825

Avelas’ ongoing Phase II/III trial is evaluating the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. This trial will enroll approximately 110 patients and is being conducted in two Periods.

Period 1 was completed in 2018 and assessed the ability of AVB-620 imaging to visualize breast cancer tumor tissue in both the in vivo and ex vivo setting.

Initial trial results were presented at San Antonio Breast Cancer Symposium 2018 (SABCS). 32 patients were dosed (31 evaluable) during at a number of prominent cancer centers across the United States. No adverse events attributable to AVB-620 were observed. The trial results reported that:

  • 35% of patients had at least one positive margin confirmed by pathology (invasive tumor on ink or DCIS < 2mm from surface, or positive shave margin)
  • 62% of patients had at least one close or positive margin confirmed by pathology (invasive tumor < 2mm or DCIS < 2mm from surface or a positive shave margin)
  • 84% of patients with positive/close margins were identified using fluorescent imaging
  • 80% of positive node patients (n=5) were identified utilizing fluorescent imaging

For more information, please visit the SABCS website (link).

Period 2 is currently recruiting patients at a number of institutions across the United States.

For more information Avelas’ clinical trials, please visit ClinicalTrials.gov.