Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and with Combination Therapies in Patients with Solid Tumors

    Cancer Categories
    • Gynecologic,Lung
    Karmanos Trial ID
    • 2024-057
    NCT ID
    • NCT05381909
    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
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Phase 1a (Dose Escalation)

    Primary Objectives:

    • To assess the safety and tolerability of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) in patients with solid tumors
    • To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended doses for expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

    Secondary Objectives:

    • To assess the preliminary antitumor activity of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT
    • To characterize the pharmacokinetic (PK) profile of BGB-24714 and its major metabolite BGB-22437 following the administration of capsules as monotherapy, in combination with chemotherapy, and in combination with cCRT

    Phase 1b (Dose Expansion)

    Primary Objectives:

    • To assess the preliminary antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

    Secondary Objectives:

    • To further evaluate the secondary measures of antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors
    • To further characterize the safety and tolerability of BGB-24714 in combination with chemotherapy in patients with selected solid tumors
    • To further characterize the PK profile of BGB-24714 and its major metabolite in combination with chemotherapy in patients with selected solid tumors
  • 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