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  • A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 in patients with advanced or metastatic solid tumors

    Cancer Categories
    • Gastrointestinal (GI),Genitourinary (GU),Lung,Sarcoma
    Karmanos Trial ID
    • 2022-086
    NCT ID
    • NCT03449381
    Age Group
    • Adult
    • 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


    Phase Ia – Dose escalation

    Primary Objectives:

    • The main objective of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose limiting toxicities (DLT) during the first treatment cycle, and the recommended dose for expansion (RDE) of BI 907828 monotherapy, and to evaluate its safety and tolerability, by monitoring the occurrence and severity of adverse events (AEs), in two different schedules (Arm A with one single dose every 21 days, Arm B with one single dose on Days 1 and 8, every 28 days).

    Secondary Objectives:

    • The determination of the pharmacokinetic (PK) profile of BI 907828 monotherapy, and the preliminary assessment of anti-tumor activity in patients with advanced or metastatic solid tumors.

    Phase Ib – Dose expansion

    Primary Objectives:

    • In dose expansion, the main objectives of Cohort 1 and Cohort 2 are to assess efficacy, and to further assess the safety and PK profiles of BI 907828 at the RDE, and to determine the RP2D of BI 907828 for TP53 wt and MDM2 amplified sarcomas, NSCLC, urothelial, gastric, biliary tract, PDAC and other tumor types.
  • 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