This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGSarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGWestern General Hospital - NHS Lothian
Edinburgh, United Kingdom
COMPLETEDThe Royal Marsden NHS Foundation and Trust
London, United Kingdom
COMPLETEDNumber of patients with treatment related adverse events and/or clinical laboratory abnormalities
Time frame: Up to 30 days post treatment
Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol
Time frame: Day 28
Part B: Objective response rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Time frame: Up to 24 months
Part B: Duration of Response (DoR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Time frame: Up to 24 months
Part B: Disease Control Rate (DCR)
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Time frame: Up to 24 months
Area under the concentration-time curve (AUC) of NXP900
Time frame: Up to 24 months
Maximum observed concentration (Cmax) of NXP900
Time frame: Up to 24 months
Time to peak concentration (Tmax) of NXP900
Time frame: Up to 24 months
Half-life (T1/2) of NXP900
Time frame: Up to 24 months
Apparent volume of distribution at steady state (Vss/F) of NXP900
Time frame: Up to 24 months
Apparent plasma clearance at steady state (Clss/F) of NXP900
Time frame: Up to 24 months
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