LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker. LOP628 provides an opportunity to target cKit overexpressing tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Barcelona, Catalonia, Spain
Incident rate of dose limiting toxicities (DLTs)
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Time frame: Month 12
Incidence of adverse events (AEs) and serious adverse events (SAE)
Characterize the safety and tolerability of LOP628
Time frame: 30 months
Severity of adverse events (AEs) and serious adverse events (SAEs)
Characterize the safety and tolerability of LOP628
Time frame: 30 months
Serum PK parameters (AUC, Cmax, Tmax, and half-life)
To characterize the pharmacokinetic profile of LOP628
Time frame: 30 months
Serum concentration vs. time profiles
To characterize the pharmacokinetic profile of LOP628.
Time frame: 30 months
Overall response rate (ORR)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months
Duration of response (DOR)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months
Progression Free Survival (PFS)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months
Disease Control Rate (DCR) at 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To assess the preliminary anti-tumor activity of LOP628
Time frame: 4 months
Best overall response (BOR)
To assess the preliminary anti-tumor activity of LOP628 in patients
Time frame: 30 months
Best Overall Response (AML)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months
Duration of response (DOR) (AML)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months
Event Free Survival (EFS) (AML)
To assess the preliminary anti-tumor activity of LOP628
Time frame: 30 months