Trial | NCT02482168  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    apx005m ...

  • Study Participants

    43
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
Study Started
May 31
2015
Primary Completion
Jun 13
2018
Study Completion
Jun 19
2018
Last Update
Dec 20
2023

Drug APX005M

APX005M is a CD40 agonistic monoclonal antibody

APX005M every 3 week Experimental

Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.

APX005M every 2 week Experimental

Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.

APX005M every 1 week Experimental

Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.

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
No Results Posted