Actively Recruiting
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Led by Kumquat Biosciences Inc. · Updated on 2026-03-03
84
Participants Needed
15
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
CONDITIONS
Official Title
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of solid tumor malignancy
- Unresectable or metastatic disease that has progressed on immunotherapy
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST v1.1
You will not qualify if you...
- Active primary central nervous system tumors
- Cardiac abnormalities
- History of lung diseases
- Any condition that may impair drug absorption or prevent oral dosing
- Known history of immune-mediated colitis and uncontrolled autoimmune diseases
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
4
Yale Cancer Center- New Haven
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
11
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Actively Recruiting
12
UT MD Anderson Cancer Center - Houston
Houston, Texas, United States, 77030
Actively Recruiting
13
NEXT Huston
Houston, Texas, United States, 77054
Actively Recruiting
14
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
15
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
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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