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A Study of LY3022855 In Participants With Breast or Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of LY3022855 In Participants With Breast or Prostate Cancer

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

NCT02265536•Eli Lilly and Company

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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
+12 more criteria

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,
•* 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.
+4 more criteria

Locations (2)

Cedars Sinai Medical Center

Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

May 1, 2015

Primary Completion Date

November 3, 2017

Completion Date

November 3, 2017

Last Updated

October 28, 2024

Enrollment

ACTUAL participants

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

LY3022855

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3022855 In Participants With Breast or Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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