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  • Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel + HM30181A) in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

    Cancer Categories
    • Lung
    Karmanos Trial ID
    • 2022-020
    NCT ID
    • NCT03588039
    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

    Objective:

    Primary Objectives:

    • Dose Escalation: To determine the MTD and identify the recommended Phase 2 dose (RP2D) of paclitaxel administered as Oraxol in combination with pembrolizumab in subjects with advanced solid tumors
    • Dose Expansion: To assess the ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.121 associated with Oraxol administered in combination with pembrolizumab in subjects with NSCLC or advanced/metastatic gastric/gastroesophageal cancer

    Secondary Objectives:

    Dose Escalation:

    • To evaluate the safety, tolerability, and DLTs of Oraxol when administered in combination with pembrolizumab in subjects with advanced solid tumors
    • To describe the pharmacokinetics of oral paclitaxel and its metabolites, when administered as Oraxol in combination with pembrolizumab in subjects with advanced solid tumors
    • To evaluate the activity of Oraxol in combination with pembrolizumab in subjects with advanced solid tumors

    Dose Expansion:

    In subjects with NSCLC or advanced gastric/gastro-esophageal cancer, the secondary
    objectives are:

    • To evaluate the safety and tolerability of Oraxol administered in combination with pembrolizumab
    • To evaluate the disease control rate (DCR) and DOR associated with Oraxol administered in combination with pembrolizumab
    • To determine the time to response associated with Oraxol administered in combination with pembrolizumab
    • To determine the OS and PFS after the initiation of treatment with Oraxol and pembrolizumab
    • To describe the pharmacokinetics of oral paclitaxel and its metabolites, when administered as Oraxol in combination with pembrolizumab
  • 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