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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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

Eligibility

  • 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

Study details
    Advanced Solid Tumors
    Colorectal Cancer (CRC)
    Non-Small Cell Lung Cancer
    Uterine Cancer
    KRAS G12C Mutations
    KRAS G12S Mutations

NCT07542704

Kumquat Biosciences Inc.

7 November 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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