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  • A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in combination with nivolumab in adults with advanced solid tumors

    Cancer Categories
    • Gastrointestinal (GI),Lung
    Karmanos Trial ID
    • 2021-039
    NCT ID
    • NCT04731467
    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/II
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Part A - Dose Escalation Phase of CM24 in Combination with Nivolumab

    Primary Objectives

    • To assess the safety, tolerability and the maximum tolerated dose (MTD) of CM24 in combination with 480mg nivolumab in adults with selected recurrent or metastatic solid tumors.
    • Determine the recommended Phase 2 dose level (RP2D) of CM24 in combination with nivolumab

    Part B - Expansion Phase of CM24 in combination with nivolumab in patients with NSCLC

    Primary Objective

    • To assess the efficacy of the recommended phase 2 dose (RP2D) of CM24 in combination with nivolumab in adults with immune-checkpoint refractory recurrent or metastatic NSCLC based on Objective Response Rate (ORR).

    Part C - Expansion Phase of CM24 in combination with nivolumab and nab-paclitaxel in patients with pancreatic adenocarcinoma

    Primary Objective

    • To assess the efficacy of CM24 in combination with nivolumab and nab-paclitaxel in adults with metastatic pancreatic cancer based on Objective Response Rate.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266