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  • A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors - ARTISTRY-1

    Cancer Categories
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Karmanos Trial ID
    • 2016-037
    NCT ID
    • NCT02799095
    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
    • Ira
      Winer, M.D., Ph.D.

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary:
    1. To investigate the safety and tolerability of ALKS 4230 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALKS 4230 in subjects with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
    2. To further characterize the safety profile of ALKS 4230 at the RP2D in subjects with specified tumor types who have previously received specified prior therapies known to provide clinical benefit.
    Secondary:
    1. To describe the dose-limiting toxicity (DLT) of ALKS 4230
    2. To describe the adverse event (AE) profile of ALKS 4230
    3. To characterize the clinical pharmacokinetic (PK) profile and immunogenicity of ALKS 4230
    4. To investigate the clinical pharmacodynamic effects of ALKS 4230
    5. To describe any antitumor activity and responses observed with ALKS 4230.
    6. To describe the AE profile of ALKS 4230
    7. To characterize the clinical PK profile and immunogenicity of ALKS 4230
    8. To investigate the clinical pharmacodynamic effects of ALKS 4230
    9. To evaluate the overall response rate (ORR) and duration of response (DOR) for subjects treated with ALKS 4230 in each of the expansion cohorts.
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    Detroit, MI 48201
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