A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies

Recruiting now · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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?

Key facts

Study ID

NCT07207707

Run by

Kumquat Biosciences Inc.

People needed

78

Starts

2025-09-16

Expected to finish

2027-03-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — La Jolla, California, United States (enrolling)
• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• SCRI - Denver — Denver, Colorado, United States (enrolling)
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• NEXT Oncology - Austin — Austin, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology - Dallas — Irving, Texas, United States (enrolling)
• NEXT Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
• University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Fred Hutchison Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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