A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Milan, MI, Italy
Incidence rate of dose limiting toxicities
Time frame: 28 days
Incidence and severity of serious/adverse events
Time frame: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic parameter Cmax
Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug
Time frame: 84 days
Presence of PCA062 anti-bodies
The presence and/or concentration of the anti-bodies will be tested from the blood samples collected
Time frame: 84 days
Overall response rate
Time frame: Duration of study (each treatment cycle = 14 days)
Duration of response
Time frame: Duration of study (each treatment cycle = 14 days)
Progression free survival
Time frame: 18 months
Disease control rate
Time frame: 18 months
Best overall response
Time frame: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic paramater Tmax
Tmax = the time the drug takes to reach maximum (peak) concentration in the blood
Time frame: 84 days
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Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Madrid, Spain