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
University of California, San Diego
La Jolla, California, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, 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.
SCRI - Denver
Denver, Colorado, United States
RECRUITINGUniversity of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGThe Christ Hospital
Cincinnati, Ohio, United States
RECRUITINGNEXT Oncology - Austin
Austin, Texas, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology - Dallas
Irving, Texas, United States
RECRUITINGNEXT Oncology - San Antonio
San Antonio, Texas, United States
RECRUITING...and 2 more locations
Peak 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