Study of the CD40 Agonistic Monoclonal Antibody APX005M



Status:Active, not recruiting
Conditions:Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:May 2015
End Date:December 2018

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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

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
We found this trial at
3
sites
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Duarte, California 91010
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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