Study of the CD40 Agonistic Monoclonal Antibody APX005M

Cancer Clinical Trial

Official title: Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Transitional Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Melanoma
• MSI-H
• NSCLC
• Urothelial Carcinoma

• NCT number: NCT02482168
• Study type: Interventional
• Source: Apexigen America, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 2015
• Completion date: June 19, 2018