Clinical Trials /

A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

NCT02529553

Description:

The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.

Related Conditions:
  • Cancer
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

Title

  • Brief Title: A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
  • Official Title: A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer
  • Clinical Trial IDs

    NCT ID: NCT02529553

    ORG ID: 15383

    NCI ID: I7O-MC-JOBA

    Trial Conditions

    Advanced Cancer

    Metastatic Cancer

    Trial Interventions

    Drug Synonyms Arms
    LY3076226 LY3076226

    Trial Purpose

    The main purpose of this study is to evaluate the safety of the study drug known as
    LY3076226 in participants with advanced or metastatic cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    LY3076226 Experimental Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle. Part C (dose expansion in other malignancies): LY3076226 administered IV on day 1 of each 21 day cycle. LY3076226

    Eligibility Criteria

    Inclusion Criteria:

    - Have advanced or metastatic cancer and be an appropriate candidate for experimental
    therapy.

    - Part B: Have a diagnosis of bladder cancer.

    - Part B and C: Have alterations of FGFR3.

    - Have adequate organ function.

    - Have discontinued previous treatments for cancer and have resolution, except where
    otherwise stated in the inclusion criteria, of all clinically significant toxic
    effects of prior chemotherapy, surgery, or radiotherapy to Grade 1 by National
    Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE),
    Version 4.0 (v 4.0).

    - If participant is of reproductive potential, must agree to use medically approved
    contraceptive precautions during the study and for 3 months following the last dose
    of study drug. If the participant is a female of childbearing potential, must have
    had a negative serum or urine pregnancy test within 7 days of the first dose of study
    drug and must not be breastfeeding.

    Exclusion Criteria:

    - Have received treatment within 28 days of the initial dose of study drug with an
    investigational product or non-approved use of a drug or device (other than the study
    drug/device used in this study) or are concurrently enrolled in any other type of
    medical research judged not to be scientifically or medically compatible with this
    study.

    - Have preexisting corneal disease that may interfere with assessment for potential eye
    toxicity during the study.

    - Have preexisting Grade 2 skin disorder (for example, erythema, dermatitis).

    - Have serious preexisting medical conditions (left to the discretion of the
    investigator).

    - Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
    required). Participants with treated CNS metastases are eligible for this study if
    they are not currently receiving corticosteroids and/or anticonvulsants, and their
    disease is asymptomatic and radiographically stable for at least 28 days.

    - Have current acute or chronic leukemia.

    - Have an active fungal, bacterial, and/or known viral infection including human
    immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not
    required).

    - Have a second primary malignancy that, in the judgment of the investigator and
    sponsor, may affect the interpretation of results. Curatively treated nonmelanoma
    skin cancer or in situ carcinoma of any origin is allowed.

    - Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening
    electrocardiogram (ECG).

    - Have a serious cardiac condition, such as congestive heart failure; New York Heart
    Association Class III/IV heart disease; unstable angina pectoris; myocardial
    infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed
    clinically significant; or arrhythmias that are symptomatic or require treatment (not
    including participants with rate-controlled atrial fibrillation).

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum Tolerated Dose (MTD) of LY3076226

    Secondary Outcome Measures

    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226

    PK: Area Under the Concentration-Time Curve (AUC) of LY3076226

    Number of Participants with Tumor Response

    Trial Keywords

    bladder cancer