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  • A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2023-094
    NCT ID
    • NCT05006716
    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
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    BGB-16673 Monotherapy Dose Finding (Phase 1)

    Primary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To define the maximum tolerated dose (or maximum assessed dose) and the
      recommended Phase 2 dose (RP2D) of BGB-16673

    Secondary Objectives:

    • To characterize the pharmacokinetic profile of BGB-16673 as monotherapy
    • To characterize the pharmacodynamic profile of BGB-16673 in peripheral blood
    • To characterize the preliminary antitumor activity of BGB-16673 monotherapy

    BGB-16673 Monotherapy (Phase 2)

    Primary Objectives:

    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with
      relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on overall response
      rate (ORR) as assessed by an Independent Review Committee (IRC)
    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with R/R
      CLL/SLL based on ORR as assessed by investigators

    Secondary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To further characterize the pharmacokinetic profile of BGB-16673
    • To further characterize the pharmacodynamic profile of BGB-16673 in peripheral
      blood
    • Patients with R/R MCL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR as
        assessed by investigators
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on best
        overall response (BOR), time to response (TTR), duration of response (DOR), and
        progression-free survival (PFS) as assessed by the IRC and investigators
      • To characterize overall survival
      • To measure patient-reported outcomes (PRO) in R/R MCL patients via National
        Comprehensive Cancer Network Functional Assessment of Cancer Therapy –
        Lymphoma System Index-18 (NFLymSI-18)
    • Patients with R/R CLL/SLL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR,
        DOR, TTR, and PFS as assessed by investigators
      • To characterize overall survival
  • 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