Solid Tumor Malignancies
Conditions
Keywords
KRAS, G12D
Brief summary
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?
Interventions
DRUGKQB548
Oral KQB548
Sponsors
Kumquat Biosciences Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Requires treatment with a proton-pump inhibitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety,Tolerability, MTD/MAD and/or RDE in the Study Population | Up to 30 months | Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration-time curve (AUC) | Up to 30 months | — |
| Maximum plasma concentration (Cmax) | Up to 30 months | — |
| Time to maximum plasma concentration (tmax) | Up to 30 months | — |
| Overall Response Rate (ORR) | Up to 30 months | Per RECIST v1.1 |
| Duration of Response (DOR) | Up to 30 months | Per RECIST v1.1 |
| Time to Response (TTR) | Up to 30 months | Per RECIST v1.1 |
| Disease Control Rate (DCR) | Up to 30 months | Per RECIST v1.1 |
| Progression Free Survival (PFS) | Up to 30 months | Per RECIST 1.1 |
| Overall Survival (OS) | Up to 30 months | Per RECIST v1.1 |
| Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect | Up to 30 months | — |
| Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect | Up to 30 months | — |
| Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect | Up to 30 months | — |
| Evaluate Changes in QTc (mSec) | Up to 30 months | — |
Countries
United States
Contacts
CONTACTKumquat Clinical Development
Outcome results
None listed