A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer


Condition: Advanced Cancer, Metastatic Cancer

Intervention:

  • Drug: LY3076226

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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02529553

Sponsor: Eli Lilly and Company

Primary Outcome Measures:

  • Measure: Maximum Tolerated Dose (MTD) of LY3076226
  • Time Frame: Cycle 1 (21 Days)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
  • Time Frame: Predose Cycle 1 Day 1 through Post Dose Cycle 4 Day 1 (Approximately 3 Months)
  • Safety Issue:
  • Measure: PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
  • Time Frame: Predose Cycle 1 Day 1 through Post Dose Cycle 4 Day 1 (Approximately 3 Months)
  • Safety Issue:
  • Measure: Number of Participants with Tumor Response
  • Time Frame: Baseline through Study Completion (Estimated up to 6 Months)
  • Safety Issue:

Estimated Enrollment: 37

Study Start Date: September 2015

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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).

Contact:

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 1-317-615-4559

Locations:

  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111-2497 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29425 United States
  • The START Center for Cancer Care
  • San Antonio Texas 78229 United States
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • Vancouver British Columbia V5Z 4E6 Canada

View trial on ClinicalTrials.gov


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