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

Study Identifier:
KQB368-101
CT.gov Identifier:
NCT07542704
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Will Be Recruiting

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Study 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
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Monotherapy Dose Escalation
    • Read More
  • Drug: Drug: KQB368
  • Drug: Oral KQB368
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Will Be Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Histologically confirmed diagnosis of a solid tumorMalignancy with either a KRAS G12C or KRAS G12S mutationUnresectable or metastatic diseaseNo available treatment with curative intentAdequate organ functionMeasurable disease per RECIST v1.1Must be able to swallow with no GI condition that prevents absorption

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor