A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 As Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies with KRAS G12S or G12C Mutations

Study Identifier:
KQB365-101
CT.gov Identifier:
NCT06720987
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:

  • What is the safe dose of KQB365 by itself or in combination with cetuximab?
  • Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?
  • What happens to KQB365 in the body?
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.
  • Gene Mutations
  • Solid Tumor
  • Bowel (Colorectal)
    • 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: - Intravenous KQB365
  • Drug: Drug: KQB365
  • Drug: Experimental: Combo Therapy Dose Escalation
  • Drug: Drug:
  • Drug: - Intravenous cetuximab
  • Drug: Drug: Cetuximab
  • Drug: Experimental: Monotherapy Dose Expansion - RP2D
  • Drug: Experimental: Monotherapy Dose Expansion - RP2D-1
  • Drug: Experimental: Combo Therapy Dose Expansion - RP2D
  • Drug: Experimental: Combo Therapy Dose Expansion - RP2D-1
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
    • * PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum 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
    Exclusion criteria
    • * Active primary central nervous system tumors
    • * Cardiac abnormalities
    • * Active interstitial lung disease

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Gene Mutations
    Solid Tumor
    Bowel (Colorectal)