Phase I Dose Escalation Study of AB-16B5 in Subjects With an Advanced Solid Malignancy

Official Title

A Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AB-16B5 in Subjects With an Advanced Solid Malignancy


This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects will have a disease that has been refractory to prior therapy and is unlikely to benefit from known therapies.

Trial Description

Primary Outcome:

  • Number of participants with an adverse event as a measure of safety and tolerability
Secondary Outcome:
  • Determination of plasma concentrations of AB-16B5
  • Objective tumour responses in subjects with measurable disease according to RECIST
  • Monitoring of epithelial-to-mesenchymal (EMT) and stem cells biomarkers in peripheral blood circulating tumour cells and paired tumour biopsies

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society