Status:
RECRUITING
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
Lead Sponsor:
Kumquat Biosciences Inc.
Conditions:
Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07207707
Start Date
September 16 2025
End Date
March 1 2027
Last Update
November 26 2025
Active Locations (6)
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1
START Midwest
Grand Rapids, Michigan, United States, 49546
2
NEXT Oncology - Austin
Austin, Texas, United States, 78758
3
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
4
NEXT Oncology - San Antonio
San Antonio, Texas, United States, 78229