A Study of LY3022855 In Participants With Breast or Prostate Cancer

February 1, 2018 updated by: Eli Lilly and Company

Phase 1 Study to Identify the Immunomodulatory Activity of LY3022855 (IMC-CS4) in Patients With Advanced, Refractory Breast or Prostate Cancer

The main purpose of this study is to learn more about how the investigational drug, LY3022855, affects the immune system in participants with advanced breast or prostate cancer that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of advanced, refractory breast or prostate cancer that is evaluable by radiologic testing. Participants must have experienced tumor progression on or treatment intolerance to at least one prior therapy.

  • For participants with metastatic castrate-resistant prostate cancer only:

    • Must continue ongoing androgen deprivation therapy with castrate levels of serum testosterone <50 nanogram/deciliter (ng/dL)
    • If receiving an antiandrogen as part of first-line hormonal therapy, must have shown progression of disease off the antiandrogen prior to enrollment
    • Must be willing to continue androgen deprivation therapy while on study, if no prior orchiectomy

    • Must meet at least 1 of the following 3 criteria for progressive metastatic disease, according to Prostate Cancer Working Group 2 (PCWG2) criteria:

      • A rise in prostate-specific antigen (minimal value 2 ng/milliliter (mL); ≥3 consecutive rising values)
      • ≥2 new metastases on transaxial imaging or radionuclide bone scan
      • Soft tissue progression
    • Replacement hormone therapy initiated before study entry is permitted

    • For participants with breast cancer only:

      • May continue ongoing antiestrogen
      • Replacement hormone therapy initiated before study entry is permitted
      • May continue ongoing trastuzumab therapy
  • Have adequate organ function, including: Hepatic: Bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN. For participants with tumor involvement of the liver, AST and ALT ≤5.0 × ULN are acceptable. For participants with tumor involvement of the bone, alkaline phosphatase ≤5.0 × ULN is acceptable. Renal: Serum creatinine ≤2.0 × ULN. Absolute neutrophil count (ANC) ≥1.0 × 109/liter (L). Hemoglobin ≥9 grams per deciliter (5.58 millimoles per liter). Platelets ≥90 × 109/L.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Have discontinued all disease-modifying therapy for the primary cancer >28 days prior to initiation of study treatment. In addition, clinically significant toxicities associated with any prior therapy for the primary cancer, including investigational treatments, have resolved or stabilized to Grade ≤1 toxicity >28 days prior to initiation of study treatment with the exception of neuropathy, which must have resolved to Grade ≤2. Continuation of a stable dose (minimum of 28 days prior to study entry) of denosumab or bisphosphonate is permitted on study.
  • Willing to undergo 1 baseline and 1 posttreatment tumor biopsy procedure.
  • Male participants: Agree to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following last dose of study drug or country requirements, whichever is longer.
  • Female participants: Are women of child-bearing potential who test negative for pregnancy within 7 days prior to enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study and for 12 weeks following the last dose of the study drug and also must not be breastfeeding, OR are postmenopausal women.

Exclusion Criteria:

  • Have received treatment within 28 days prior to 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) for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have serious preexisting medical conditions (left to the discretion of the investigator).
  • Have symptomatic central nervous system (CNS) malignancy or metastasis.
  • Have an active fungal, bacterial, and/or known viral infection, including human immunodeficiency virus (HIV) or viral (B or C) hepatitis.

  • Have any of the following cardiovascular conditions:

    • Symptomatic coronary artery disease currently or within the past 6 months,
    • Confirmed left ventricular ejection fraction ≤50% or any cardiac insufficiency > New York Heart Association (NYHA) class II currently or within the past 6 months,
    • Uncontrolled hypertension (>170/100 millimeter of mercury [mm Hg]) currently or within the past 7 days, or
    • Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
  • Have corrected QT interval of >500 millisecond (msec) on screening electrocardiogram (ECG).
  • Have received treatment with agents specifically targeting colony stimulating factor 1 (CSF-1) or CSF-1R, including imatinib, nilotinib, and sunitinib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3022855 - 1.25 mg/kg Dose A
1.25 milligram per kilogram (mg/kg) LY3022855 administered intravenously (IV), once every two weeks. Treatment is 6 week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Names:
  • IMC-CS4
Experimental: LY3022855 - Dose B
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Names:
  • IMC-CS4
Experimental: LY3022855 - Dose C
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Names:
  • IMC-CS4
Experimental: LY3022855 - Dose D
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Names:
  • IMC-CS4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Peripheral Blood Immune Cell Subsets
Time Frame: Baseline to study completion, up to 6 cycles (cycle = 6 weeks)
Baseline to study completion, up to 6 cycles (cycle = 6 weeks)
Change from Baseline in Serum Cytokines
Time Frame: Baseline to study completion, up to 6 cycles (cycle = 6 weeks)
Baseline to study completion, up to 6 cycles (cycle = 6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Time Frame: Baseline up to 6 cycles (cycle = 6 weeks)
Baseline up to 6 cycles (cycle = 6 weeks)
Disease Control Rate
Time Frame: Baseline up to 6 cycles (cycle = 6 weeks)
Baseline up to 6 cycles (cycle = 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 4, 2017

Study Completion (Actual)

October 4, 2017

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15441
  • I5F-MC-JSCB (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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