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?
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
Trial sites (13)
Facility
City
Region
Status
University of California, San Diego
La Jolla
California
Recruiting
University of California, Los Angeles
Los Angeles
California
Recruiting
SCRI - Denver
Denver
Colorado
Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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