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?
Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
Measurable disease according to RECIST v1.1
Adequate organ function
Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
Poorly controlled ascites and/or pleural effusion
Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
Sequential
KQB548
DrugOral KQB548
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
Plasma Concentration-time curve (AUC)
Maximum plasma concentration (Cmax)
Time to maximum plasma concentration (tmax)
Overall Response Rate (ORR)
Per RECIST v1.1
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