The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: * What is the safe dose of KQB548? * Does KQB548 decrease the size of the tumor? * What happens to KQB548 in the body?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Oral KQB548
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGNEXT Oncology - Austin
Austin, Texas, United States
RECRUITINGNEXT Oncology - Dallas
Irving, Texas, United States
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs
Time frame: Up to 30 months
Plasma Concentration-time curve (AUC)
Time frame: Up to 30 months
Maximum plasma concentration (Cmax)
Time frame: Up to 30 months
Time to maximum plasma concentration (tmax)
Time frame: Up to 30 months
Overall Response Rate (ORR)
Per RECIST v1.1
Time frame: Up to 30 months
Duration of Response (DOR)
Per RECIST v1.1
Time frame: Up to 30 months
Time to Response (TTR)
Per RECIST v1.1
Time frame: Up to 30 months
Disease Control Rate (DCR)
Per RECIST v1.1
Time frame: Up to 30 months
Progression Free Survival (PFS)
Per RECIST 1.1
Time frame: Up to 30 months
Overall Survival (OS)
Per RECIST v1.1
Time frame: Up to 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NEXT Oncology - San Antonio
San Antonio, Texas, United States
RECRUITINGUniversity of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGPeak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Evaluate Changes in QTc (mSec)
Time frame: Up to 30 months