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
Histologically confirmed diagnosis of solid tumor malignancy.
Unresectable or metastatic disease that has progressed on immunotherapy.
No available treatment with curative intent
Adequate organ function
Active primary central nervous system tumors
Cardiac abnormalities
History of lung diseases
Any condition that may impair drug absorption or prevent oral dosing
Sequential
KQB168
DrugOral KQB168
Pembrolizumab
DrugIntravenous pembrolizumab
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.
Overall response rate (ORR)
Using RECIST v1.1
Duration of response (DOR)
Using RECIST v1.1
Time to response (TTR)
Using RECIST v1.1
Disease control rate (DCR)
Using RECIST v1.1
Click on the lead sponsor to view all of their trials.
