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A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
* Histologically confirmed diagnosis of a solid tumor * Malignancy with either a KRAS G12C or KRAS G12S mutation * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 * Must be able to swallow with no GI condition that prevents absorption
About the study
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
What is being tested
- KQB368 (drug)
Sponsor: Kumquat Biosciences Inc. · Participants: 48 · Started: May 27, 2026
Contact the study team
- Kumquat Clinical Development Telephone · Phone: 858.214.2700
Official record on ClinicalTrials.gov — NCT07542704
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.