Actively Recruiting
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
Led by Kumquat Biosciences Inc. · Updated on 2026-03-13
78
Participants Needed
12
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed, locally advanced or metastatic pancreatic ductal adenocarcinoma, colorectal cancer, or non-small cell lung cancer 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 will not qualify if you...
- Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
- History of intestinal disease or uncontrolled inflammatory bowel disease such as Crohn's disease or Ulcerative Colitis
- Major esophageal or gastric surgery or other gastrointestinal conditions likely to alter absorption or cause 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
SCRI - Denver
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
NEXT Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
10
NEXT Oncology - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
11
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Kumquat Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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