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

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


  • Org Study ID: 15383
  • Secondary ID: I7O-MC-JOBA
  • NCT ID: NCT02529553
  • NCT Alias:
  • Sponsor: Eli Lilly and Company - Industry
  • Source: Eli Lilly and Company

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: September 2015 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Maximum Tolerated Dose (MTD) of LY3076226

Primary Outcome 1 - Time Frame: Cycle 1 (21 Days)

Condition:

  • Advanced Cancer
  • 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).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: Study Director

Affiliation: Eli Lilly and Company

Overall Contact

Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email:

Link: Click here for more information about this study: A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

Locations

Facility Status Contact
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111-2497
United States
Recruiting
215-728-5673
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Recruiting
843-792-4271
The START Center for Cancer Care
San Antonio, Texas 78229
United States
Recruiting
210-593-5270
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
Recruiting Eli Lilly and Company