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  • A Phase 1 Open-label, Dose-escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

    Cancer Categories
    • Gastrointestinal (GI),Lung
    Karmanos Trial ID
    • 2023-035
    NCT ID
    • NCT05012618
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator
    • Image of Mohammed Najeeb Al Hallak , M.D., MS
      Mohammed Najeeb
      Al Hallak, M.D., MS
      Oncology - Medical View Profile

    Objective:

    Primary Objective

      The primary objectives for this study are:

      • Part A (LUNA18 monotherapy dose escalation cohorts), Part AA (LUNA18 monotherapy backfill cohorts) and Part D (LUNA18 combination dose finding cohorts):
        • To evaluate the safety and tolerability of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)
        • To determine the maximum tolerated dose (MTD) and the recommended dose (RD) when administered as a single agent (Part A) and in combination with other anti-cancer drugs (Part D)
        • To characterize the PK profile of LUNA18 in plasma when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)
      • Part B (LUNA18 monotherapy biomarker cohorts):
        • To evaluate the safety and tolerability of LUNA18
        • To evaluate the inhibition of the phosphorylation level of extracellular signal-regulated kinase (ERK) protein (pERK) and other biomarkers as applicable in tumor tissues
        • To evaluate the preliminary anti-tumor activity of LUNA18
      • Part C (LUNA18 monotherapy expansion cohorts) and Part E (LUNA18 combination expansion cohorts):
        • To evaluate the safety and tolerability of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)
        • To evaluate the preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)

        Secondary Objectives

          The secondary objectives for this study are:

          • Part A (LUNA18 monotherapy dose escalation cohorts), Part AA (LUNA18 monotherapy backfill cohorts) and Part D (LUNA18 combination dose finding cohorts):
            • To evaluate the preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)
            • To evaluate the immunogenicity of LUNA18 when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)
            • To evaluate the inhibition of the phosphorylation level of pERK and other biomarkers as applicable in tumor tissues when administered as a single agent (Part A, Part AA) and in combination with other anti-cancer drugs (Part D)
            • To evaluate the difference of LUNA18 PK between hard capsule and soft capsule (Part A, Part AA)
            • To evaluate the difference of LUNA18 PK between monotherapy (Part A, Part AA) and combination therapy (Part D)
            • To characterize PK profile and immunogenicity of other anti-cancer drugs when administered in combination with LUNA18 (Part D)
          • Part B (LUNA18 monotherapy biomarker cohorts):
            • To evaluate the additional preliminary anti-tumor activity of LUNA18
            • To characterize the PK profile and to evaluate the immunogenicity of LUNA18
          • Part C (LUNA18 monotherapy expansion cohorts) and Part E (LUNA18 combination expansion cohorts):
            • To evaluate the additional preliminary anti-tumor activity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)
            • To characterize PK profile and to evaluate the immunogenicity of LUNA18 when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)
            • To evaluate the inhibition of the phosphorylation level of pERK and other biomarkers as applicable in tumor tissues when administered as a single agent (Part C) and in combination with other anti-cancer drugs (Part E)
            • To characterize PK profile and immunogenicity of other anti-cancer drugs when administered in combination with LUNA18 (Part E)
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    • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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