This study is a phase 1 open-label dose escalation study of the immuno-activating
monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish
the maximum tolerated dose and the overall safety and tolerability of APX005M in 3
different administration schedules.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02482168.
APX005M-001 is an open-label study and comprises a dose-escalation portion of
approximately 8 dose level cohorts, plus an expansion cohort.
Eligible subjects with solid tumors will receive intravenous APX005M every 3 week, every
2 week or every 1 week until disease progression, unacceptable toxicity or death,
whichever occurs first.
Study objectives include:
- Evaluate safety of APX005M
- Determine the maximum tolerated dose of APX005M
- Determine the pharmacokinetic parameters of APX005M: the maximal drug concentration
(Cmax), area under the curve of serum concentration over time (Area Under the Curve/
AUC), and half-life (t½).
- Preliminary assessment of clinical response
Lead OrganizationApexigen America, Inc.
