Clinical Trials /

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

NCT02368951

Description:

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (<span class="go-doc-concept go-doc-biomarker">FGFR2</span>)

Title

  • Brief Title: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
  • Official Title: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
  • Clinical Trial IDs

    NCT ID: NCT02368951

    ORG ID: 16897

    Trial Conditions

    Medical Oncology

    Trial Interventions

    Drug Synonyms Arms
    BAY1187982 BAY1187982

    Trial Purpose

    To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and
    pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with
    advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    BAY1187982 Experimental Dose-escalation phase: Approximately 30 subjects will participate in the dose-escalation phase The total number of subjects will depend on the number of cohorts necessary to identify the MTD. MTD expansion phase: Once the MTD has been determined, two expansion cohorts in FGFR2 expressing indications are planned. 80 additional subjects will be enrolled to have at least 30 evaluable subjects treated at MTD in each expansion cohort.BAY1187982 BAY1187982

    Eligibility Criteria

    Inclusion Criteria:

    - All subjects must be >/= 18 years at the first screening examination / visit

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

    - Subjects with advanced, histologically or cytologically confirmed solid tumors
    described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory
    to any standard therapy

    - For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced,
    histologically or cytologically confirmed triple-negative breast cancer who had
    undergone within 4 lines of systemic anti-cancer treatment and not eligible for
    standard therapy anymore.

    - Subjects need to have evaluable disease (measurable or not measurable).

    - Women of childbearing potential must have a negative pregnancy test performed within
    7 days prior to the start of treatment

    Exclusion Criteria:

    - History of allergic reactions to monoclonal antibody therapy (or excipients in the
    formulation)

    - Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or
    cancer immunotherapy within 4 weeks prior to the first dose of the investigational
    drug.

    - Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or
    cancer immunotherapy have not normalized.

    - History of symptomatic metastatic brain or meningeal tumors unless the subject is
    longer than 3 months from the end of definitive therapy before the first dose of the
    investigational drug and has clinically or radiologically no evidence of tumor
    growth.

    - History of clinically significant cardiac disease

    - Congenital coagulation abnormalities

    - Subjects who are pregnant or are breast-feeding

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum tolerated dose(MTD)

    Number of subjects with adverse events as a measure of safety and tolerability

    Number of subjects with serious adverse events as a measure of safety and tolerability

    Secondary Outcome Measures

    Cmax (maximum observed drug concentration in measured matrix after single dose administration)

    AUC(0-tlast) AUC from time 0 to the last data point >LLOQ

    AUC)0-504 (AUC from zero to 504 hours post infusion)

    AUC (area under the concentration vs. time curve from zero to infinity after single (first)

    Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval)

    AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing)

    AUC(0-504)md

    FGFR2 levels in tumor tissue sample

    CK18 levels in tumor tissue sample

    Nucleosome level in plasma

    Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicity

    Tumor response

    Trial Keywords

    Phase 1

    Solid Tumors

    FGFR2

    Antibody drug conjugate