Not Yet RecruitingPhase 1

A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies

48 participantsStarted 2026-05

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

What they're measuring

Primary Objective

Timeframe: Up to 44 months

Trial details

NCT IDNCT07542704

SponsorKumquat Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Kumquat Clinical Development Telephone

858.214.2700 kumquatstudies@kumquatbio.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials