A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
Condition: Advanced Cancer; Metastatic Cancer
MeSH terms: Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary
Intervention: LY3076226
Intervention description: Administered IV
Intervention MeSH terms: LY3076226
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bladder cancer

Summary:

      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.
    

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: 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).