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
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.
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
Incidence of dose limiting toxicities
Blood concentrations of APX005M
Study Arms / Comparison Groups
APX005M every 3 week
Description: Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
June 19, 2018
Primary Completion Date
June 13, 2018
Key Inclusion Criteria: - Histologically documented diagnosis of solid tumor - For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high) - No known effective therapy options are available - Measurable disease by RECIST 1.1 - ECOG performance status of 0 or 1 - Adequate bone marrow, liver and kidney function - No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy - Negative pregnancy test for women of child bearing potential Key Exclusion Criteria: - Any history of or current hematologic malignancy - Major surgery or treatment with any other investigational agent within 4 weeks - Uncontrolled diabetes or hypertension - History of arterial thromboembolic event - History of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction - Active known clinically serious infections
18 Years - N/A
Accepts Healthy Volunteers
Medical Director, ,
Medical Director, Study Director, Apexigen, Inc.