A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors

Study Identifier:
MK-4716-001
CT.gov Identifier:
NCT07247110
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.

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.
  • Unspecified Cancer
    • 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: MK-4716 + Cetuximab
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  • Drug: Participants will receive MK-4716 + Cetuximab
  • Drug: Drug: Cetuximab
  • Drug: Intravenous administration
  • Drug: Drug: MK-4716
  • Drug: Oral administration
  • Drug: EXPERIMENTAL: MK-4716 Dose Escalation
  • Drug: Participants receive MK-4716 at varying dose levels and schedules.
  • Drug: EXPERIMENTAL: MK-4716 + Pembrolizumab
  • Drug: Participants will receive MK-4716 + Pembrolizumab
  • Drug: Drug: Pembrolizumab
  • Drug: Other Names: Keytruda, MK-3475
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor
    • * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
    • * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
    • * Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
    • * Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
    • * Arm MK-4716 + Pembrolizumab: Must be untreated
    • * Has measurable disease
    • * Has the ability to swallow and retain oral medication
    Exclusion criteria
    • Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
    • * Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
    • * Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
    • * History of human immunodeficiency virus infection
    • * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
    • * Has a known active central nervous system metastases and/or carcinomatous meningitis
    • * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • * Has active infection requiring systemic therapy
    • * Has Hepatitis B or Hepatitis C virus infection
    • * History of stem cell/solid organ transplant
    • * Has not adequately recovered from major surgery or has ongoing surgical complications

    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
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer