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A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Sponsor: Kumquat Biosciences Inc.
Summary
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
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-06-24
Completion Date
2028-05-31
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
KQB168
Oral KQB168
Pembrolizumab
Intravenous pembrolizumab
Locations (15)
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States
Yale Cancer Center- New Haven
New Haven, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
NEXT Austin
Austin, Texas, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
UT MD Anderson Cancer Center - Houston
Houston, Texas, United States
NEXT Huston
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States