A Study of LY3164530 in Participants With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02221882
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.

Condition or disease Intervention/treatment Phase
Neoplasms Neoplasm Metastasis Drug: LY3164530 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting MET and EGFR, in Patients With Advanced or Metastatic Cancer
Study Start Date : August 2014
Actual Primary Completion Date : March 7, 2017
Actual Study Completion Date : March 7, 2017

Arm Intervention/treatment
Experimental: LY3164530
LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3164530
Administered IV.

Primary Outcome Measures :
  1. Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (Cycle = 28 days) ]
    Recommended Phase 2 Dose of LY3164530: MTD

Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
    Cmax of LY3164530

  2. Area Under the Plasma Concentration-Time Curve of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
    Area Under the Plasma Concentration-Time Curve of LY3164530

  3. Number of Participants with Tumor Response [ Time Frame: Baseline through study completion (estimated as up to 6 months for each participant) ]
    Number of Participants with Tumor Response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
  • Have adequate organ function.
  • Prior Treatments:

    • Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:

      • Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
      • Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
    • Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
  • If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three 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 14 days of the first dose of study drug and must not be breast feeding.

Exclusion Criteria:

  • Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
  • Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
  • Must not have a serious preexisting medical conditions or concomitant disorders.
  • Must not have leukemia.
  • Must not have QT interval of >470 millisecond.
  • Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02221882

United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company Identifier: NCT02221882     History of Changes
Other Study ID Numbers: 15279
I7H-MC-JNBA ( Other Identifier: Eli Lilly and Company )
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes