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A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
Sponsor: Kumquat Biosciences Inc.
Summary
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-05-27
Completion Date
2029-12
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
KQB368
Oral KQB368
Locations (14)
START Los Angeles
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology Austin
Austin, Texas, United States
START Dallas Fort Worth
Dallas, Texas, United States
START San Antonio
San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States