NCT02482168

Study of the CD40 Agonistic Monoclonal Antibody APX005M

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Apexigen America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cancer
• NSCLC
• Melanoma
• Urothelial Carcinoma
• MSI-H
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	APX005M	APX005M is a CD40 agonistic monoclonal antibody

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-06-13
• Completion: 2018-06-19
• First posted: 2015-06-26
• Last updated: 2023-12-20

Locations

3 sites across 1 country: United States