The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Oral KQB168
Intravenous pembrolizumab
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGSarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States
RECRUITINGYale Cancer Center- New Haven
New Haven, Connecticut, United States
RECRUITINGMayo Clinic - Jacksonville
Jacksonville, Florida, United States
RECRUITINGFlorida Cancer Specialists - Sarasota
Sarasota, Florida, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGMayo Clinic - Rochester
Rochester, Minnesota, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGNEXT Austin
Austin, Texas, United States
RECRUITING...and 5 more locations
Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
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 36 months
Overall response rate (ORR)
Using RECIST v1.1
Time frame: up to 36 months
Duration of response (DOR)
Using RECIST v1.1
Time frame: up to 36 months
Time to response (TTR)
Using RECIST v1.1
Time frame: up to 36 months
Disease control rate (DCR)
Using RECIST v1.1
Time frame: up to 36 months
Progression-free survival (PFS)
Using RECIST v1.1
Time frame: up to 36 months
Overall survival (OS)
using RECIST v1.1
Time frame: up to 36 months
Concentration-time curve (AUC)
Time frame: up to 36 months
Maximum plasma concentration (Cmax)
Time frame: up to 36 months
Time to maximum plasma concentration (tmax)
Time frame: up to 36 months
Pharmacologically Active Dose (PAD)
Assessment of tumor and systemic immune activation
Time frame: up to 36 months
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