This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.
The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Site Reference ID/Investigator# 53365
Scottsdale, Arizona, United States
Site Reference ID/Investigator# 53364
Aurora, Colorado, United States
Maximum tolerated dose
Time frame: after four weeks of dosing
The incidence and frequency of dose-limiting toxicities; The frequency, severity, and relationship of adverse events and serious adverse events;Incidence of abnormal findings in physical examinations and clinical laboratory values
Time frame: during estimated average 4 month treatment period and 90 day follow up
Pharmacokinetic profile of PDL192 including maximum serum drug concentration, area under the concentration-time curve from time zero to infinity, systemic clearance, volume of distribution, and elimination half-life
Time frame: during estimated average 4 month treatment period and 90 day follow up
Incidence of PDL192-specific antidrug antibodies
Time frame: during estimated average 4 month treatment period and 90 day follow up
Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease)
Time frame: during estimated average 4 month treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.