A Study of LY3022855 In Participants With Breast or Prostate Cancer

NCT02265536 | Completed Phase 1 Results

• 2 other identifiers: 15441I5F-MC-JSCB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (3)

• Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets

  The immunomodulatory activity of the drug was documented by examining markers that include, but are not limited to: Live-Dead, Cluster of Differentiation 3 (CD3), CD4, CD8, CD14, CD16, Foxhead Box p3 (FoxP3), PD-1, Ki-67, Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), Human Leukocyte Antigen-D-relate (HLA-DR), T-cell immunoglobulin and mucin-3 (TIM-3), lymphocyte-activation gene 3 (LAG-3), and Inducible T-cell COStimulator (ICOS). The expression of these markers was quantified by flow cytometric analysis with an antibody panel.

  Baseline to Day 8 after 1st dose

• Percentage Change From Baseline in Serum Cytokines

  The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokine levels was determined by MSD multiplex cytokine immunoassay technology or ELISA, and that may include but not be limited to Interleukin 6 (IL-6), IL-8, IL-10 and Tumor necrosis factor (TNF-α).

  Baseline to Day 8 after 1st dose

• Serum Cytokine Levels

  The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokines will be determined by MSD multiplex cytokine immunoassay or ELISA. The markers to be measured using these technologies include, but are not limited to: CSF-1, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-34, and TNF-α.

  Day 8

Secondary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855

  0, 1, 4, 24, 48, 72 and 168 hours post dose on Day 1 and Day 29

• Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)

  Baseline up to 6 cycles (cycle = 6 weeks)

Study Arms (4)

LY3022855 1.25 mg/kg Q2W

EXPERIMENTAL

1.25 milligram per kilogram (mg/kg) LY3022855 administered intravenously (IV), once every two weeks (Q2W). Treatment is 6 week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.

Drug: LY3022855

LY3022855 1.0 mg/kg WK1_2_4_5

EXPERIMENTAL

1.0 mg/kg LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.

Drug: LY3022855

LY3022855 100 mg Q2W

EXPERIMENTAL

100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.

Drug: LY3022855

LY3022855 100 mg QW

EXPERIMENTAL

100 mg of LY3022855 administered IV. once a week (QW) of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.

Drug: LY3022855

Interventions

LY3022855 DRUG

Administered IV

Also known as: IMC-CS4

LY3022855 1.0 mg/kg WK1_2_4_5; LY3022855 1.25 mg/kg Q2W; LY3022855 100 mg Q2W; LY3022855 100 mg QW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and have declined or are ineligible for a standard treatment.
• 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) determined within 4 weeks prior to starting treatment
• 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 therapy
• Replacement hormone therapy initiated before study entry is permitted
• May continue ongoing trastuzumab therapy
• Have adequate organ and hematologic 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 × 10\^9/liter (L). Hemoglobin ≥9 grams per deciliter (5.58 millimoles per liter). Platelets ≥90 × 10\^9/L.

You may not qualify if:

• 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,
• Have a second active primary malignancy that, in the judgment of the investigator or sponsor, may affect the interpretation of the results.
• 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 a second active primary malignancy that, in the judgment of the investigator or sponsor, may affect the interpretation of the results.
• Are unwilling or unable to participate in tumor biopsies.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Autio KA, Klebanoff CA, Schaer D, Kauh JSW, Slovin SF, Adamow M, Blinder VS, Brahmachary M, Carlsen M, Comen E, Danila DC, Doman TN, Durack JC, Fox JJ, Gluskin JS, Hoffman DM, Kang S, Kang P, Landa J, McAndrew PF, Modi S, Morris MJ, Novosiadly R, Rathkopf DE, Sanford R, Chapman SC, Tate CM, Yu D, Wong P, McArthur HL. Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study. Clin Cancer Res. 2020 Nov 1;26(21):5609-5620. doi: 10.1158/1078-0432.CCR-20-0855. Epub 2020 Aug 26.

  PMID: 32847933 DERIVED

Related Links

• A Study of LY3022855 In Participants With Breast or Prostate Cancer

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

LY3022855

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 16, 2014
• Study Start: May 1, 2015
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)