Study of the CD40 Agonistic Monoclonal Antibody APX005M

• Status: Completed
• Trial end date: 2018-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apexigen, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

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