A Phase I, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Study Identifier:
INCB 161734-101
CT.gov Identifier:
NCT06179160
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-507091-47-00
Study Contact Information:
N/A
Recruiting

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Study Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies. To assess safety, efficacy, pharmacokinetics, PD, and identify recommended doses for expansion.

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: Part 1a: Dose Escalation monotherapy
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  • Drug: Chemotherapy Regimens
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • ≥18 years old.Locally advanced or metastatic solid tumor with KRAS G12D mutation.For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.Cohort specific requirements aas defined in the protocol.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    Exclusion criteria
    • Prior treatment with any KRAS G12D inhibitorKnown additional invasive malignancy within 1 year of the first dose of study drugHistory of organ transplant, including allogeneic stem cell transplantationSignificant, uncontrolled medical conditionHistory or presence of an ECG abnormalityInadequate organ functionOther protocol-defined Inclusion/Exclusion Criteria may apply

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Manuel Pedregal Trujillo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor