The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Oral KQB368
Primary Objective
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.
Time frame: Up to 44 months
Objective response rate (ORR)
Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria (RECISTv1.1). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from first dose of study treatment until last dose.
Time frame: Up to 44 months
Overall survival (OS)
Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.
Time frame: Up to 44 months
Duration of response (DOR)
Duration of response is defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.
Time frame: Up to 44 months
Time to response (TTR)
Time to response is defined as time from first dose of study treatment to date of first documentation of objective tumor response (CR or PR) based on RECIST v1.1.
Time frame: Up to 44 months
Disease control rate (DCR)
Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from first dose of study treatment until last dose.
Time frame: Up to 44 months
Progression-free survival (PFS)
Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 44 months
Area under the concentration-time curve (AUC)
Time frame: Up to 44 months
Maximum plasma concentration (Cmax)
Time frame: Up to 44 months
Time to maximum plasma concentration (tmax)
Time frame: Up to 44 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.