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 |
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.
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
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
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
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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