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

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

  • ORG STUDY ID: 15383
  • SECONDARY ID: I7O-MC-JOBA
  • NCT ID: NCT02529553

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
LY3076226LY3076226

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.

Trial Arms

NameTypeDescriptionInterventions
LY3076226ExperimentalPart 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.
  • 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: 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of LY3076226
Time Frame:Cycle 1 (21 Days)
Safety Issue:
Description:The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Time Frame:Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Safety Issue:
Description:
Measure:PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Time Frame:Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Safety Issue:
Description:
Measure:Number of Participants With Tumor Response
Time Frame:Baseline through Study Completion (Cycle 3, day 21)
Safety Issue:
Description:Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • bladder cancer

Last Updated

April 17, 2020