NeoplasmsPhase 1NCT02265536

A Study of LY3022855 In Participants With Breast or Prostate Cancer

A Phase 1 study testing LY3022855 in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Neoplasm Metastasis
What is being tested?: LY3022855
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: 1 May 2015to 3 Nov 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 22Show fewer

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.
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 and able to comply with study procedures including 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.
Have an estimated life expectancy that, in the judgment of the investigator, will permit the patient to complete 1 cycle of treatment.
May have received treatment with an investigational product or non-approved use of a drug (other than the study drug used in this study) or device for non-cancer indications; however, not within 28 days prior to the initial dose of study drug.

Who cannot join

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,

Show all 14Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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

Conditions: Neoplasms, Neoplasm Metastasis
Being tested: LY3022855
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3022855Drug
Also called IMC-CS4
Administered IV

Study groups in NCT02265536
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: LY3022855

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: Day 8

Secondary outcomes (2)

Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Area under the concentration versus time curve from time zero to tau (τ) of LY3022855 (AUC[0- τ]), where tau is dosing interval of (0-14 days).
Measured: 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)
Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Measured: Baseline up to 6 cycles (cycle = 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20153 Nov 2017

First posted16 Oct 2014 (estimated)
Study start1 May 2015
Primary completion3 Nov 2017
Study completion3 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265536
Sponsor's protocol ID: 15441
Other IDs: I5F-MC-JSCB
Status last verified: Oct 2024
First submitted: 24 Sep 2014
Last updated: 28 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 32847933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Study to Identify the Immunomodulatory Activity of LY3022855 (IMC-CS4) in Patients With Advanced, Refractory Breast or Prostate Cancer
ClinicalTrials.gov ID: NCT02265536
Acronym / sponsor ID: 15441
Conditions: Neoplasms, Neoplasm Metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 1 May 2015 (actual)
Primary completion: 3 Nov 2017 (actual)
Study completion: 3 Nov 2017 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Posted 28 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
LY3022855 1.25 mg/kg Q2W	Experimental	Drug: LY30228551.25 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.
LY3022855 1.0 mg/kg WK1_2_4_5	Experimental	Drug: LY30228551.0 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.
LY3022855 100 mg Q2W	Experimental	Drug: LY3022855100 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.
LY3022855 100 mg QW	Experimental	Drug: LY3022855100 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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:
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.
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.

Key exclusion criteria (14 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3022855Also: IMC-CS4Administered IV	Drug	LY3022855 1.0 mg/kg WK1_2_4_5, LY3022855 1.25 mg/kg Q2W, LY3022855 100 mg Q2W, LY3022855 100 mg QW

Primary outcome

Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
Time frame: Baseline to Day 8 after 1st dose
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.
Percentage Change From Baseline in Serum Cytokines
Time frame: Baseline to Day 8 after 1st dose
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).
Serum Cytokine Levels
Time frame: Day 8
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.

2 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Time frame: 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)
Time frame: Baseline up to 6 cycles (cycle = 6 weeks)

Results and safety

Results posted to the registry on 28 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY3022855 - 1.25 mg/kg Q2W Breast Cancer	6	5
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer	5	2
LY3022855 - 100 mg Q2W Breast Cancer	5	5
LY3022855 - 100 mg QW Breast Cancer	6	6
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer	8	5
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer	4	4

Primary outcome: Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets

Time frame: Baseline to Day 8 after 1st dose. Median (Inter-Quartile Range). Unit: Percent Change

Measure	LY3022855 - 1.25 mg/kg Q2W Breast Cancer n = 6	LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer n = 5	LY3022855 - 100 mg Q2W Breast Cancer n = 5	LY3022855 - 100 mg QW Breast Cancer n = 6	LY3022855 - 1.25 mg/kg Q2W Prostate Cancer n = 8	LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer n = 4
C14_HLA_DR_%	-10.31 (-39.58 to -9.05)	5.12 (1.54 to 26.3)	-16.39 (-21.73 to -11.05)	-26.76 (-28.66 to -24.87)	-11.77 (-19.97 to -1.71)	-11.72 (-15.71 to -7.73)
LIVE_CELL_Count (CNT)	-9.85 (-13.45 to -3.18)	-20.08 (-26.37 to -1.67)	-12.82 (-39.07 to 4.13)	1.23 (-7.11 to 10.71)	0.43 (-10.33 to 7.02)	-3.48 (-3.82 to -3.28)
CD3_CNT	-10.53 (-24.82 to -0.59)	39.23 (-8.69 to 77.95)	1.92 (-20.92 to 16.58)	-19.27 (-27.82 to 17.61)	12.35 (-3.29 to 19.26)	-2.35 (-10.44 to 8.31)
CD3_LIVE_%	-3.54 (-17.62 to 5.09)	16.63 (-11.76 to 33.86)	20.32 (13.89 to 36.08)	-5.33 (-8.5 to 4.87)	8.11 (-4.29 to 20.15)	-5.11 (-10.76 to -1.17)
CD4_CD3_%	1.81 (-2.97 to 9.84)	3.18 (-0.35 to 5.16)	-3.01 (-4.49 to 0.29)	-0.15 (-14.67 to 10.5)	0.41 (-1.24 to 1.67)	7.34 (0 to 10.65)
CD4_CNT	-13.02 (-22.31 to 2.58)	43.43 (-6.95 to 86.22)	2.87 (-17.63 to 13.04)	-18.79 (-38.14 to 17.61)	11.31 (-2.75 to 18.02)	4.65 (-1.27 to 7.45)
CD8_CD3_%	-4.02 (-10.44 to 4.76)	-4.5 (-9.56 to 3.45)	1.96 (-7.73 to 8.53)	28.25 (13.74 to 37.77)	0 (-8.71 to 4.82)	-9.91 (-16.93 to 11.77)
CD8_CD4_RATIO	-5.53 (-18.34 to 7.93)	-7.44 (-13.77 to 4.7)	0.01 (-10.97 to 11.13)	32.87 (21 to 49.28)	0.4 (-11.34 to 5.67)	-16.13 (-24.67 to 14.1)

Population analysed: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for peripheral blood immune cell subsets.

Primary outcome: Percentage Change From Baseline in Serum Cytokines

Time frame: Baseline to Day 8 after 1st dose. Median (Inter-Quartile Range). Unit: Percent Change

Measure	LY3022855 - 1.25 mg/kg Q2W Breast Cancer n = 6	LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer n = 5	LY3022855 - 100 mg Q2W Breast Cancer n = 5	LY3022855 - 100 mg QW Breast Cancer n = 6	LY3022855 - 1.25 mg/kg Q2W Prostate Cancer n = 8	LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer n = 4
TNF-α	-14.51 (-19.84 to 81.88)	48.28 (16.56 to 61.5)	416.95 (416.95 to 416.95)	3.51 (-21.14 to 14.91)	6.1 (-14.11 to 61.5)	–
IL-8	24.53 (18.82 to 7901)	62.84 (-38.78 to 189.47)	1956.66 (1108.74 to 2804.58)	-19.97 (-41.55 to 435.42)	67.42 (29.18 to 122.35)	-7.62 (-51.64 to 57.42)
IL-6	18.13 (-38.15 to 35.79)	35.76 (-9.31 to 72.08)	1956.66 (1108.74 to 2804.58)	-19.97 (-41.55 to 435.42)	67.42 (29.18 to 122.35)	-7.62 (-51.64 to 57.42)
IL-10	83.3 (45.6 to 94.11)	12.69 (-41.7 to 95.05)	–	–	174.75 (139.08 to 191.88)	–

Population analysed: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.

Primary outcome: Serum Cytokine Levels

Time frame: Day 8. Median (Inter-Quartile Range). Unit: nanograms per liter (ng/L)

Measure	LY3022855 - 1.25 mg/kg Q2W Breast Cancer n = 6	LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer n = 4	LY3022855 - 100 mg Q2W Breast Cancer n = 5	LY3022855 - 100 mg QW Breast Cancer n = 5	LY3022855 - 1.25 mg/kg Q2W Prostate Cancer n = 7	LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer n = 4
CSF-1	308460 (182347.5 to 358665)	23564.3 (511.4 to 70952.5)	290520 (792.8 to 328780)	470350 (335340 to 472700)	235950 (67192 to 247580)	159550 (81224.5 to 211830)
IL-34	670.6 (425.75 to 766.08)	137.56 (62.5 to 257.73)	498.89 (62.5 to 637.28)	447.11 (357.36 to 737.66)	392.54 (145.57 to 517.92)	123.44 (106.27 to 167.87)

Population analysed: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 133 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY3022855 - 1.25 mg/kg Q2W Breast Cancer	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer	1 of 5 (20%)	5 of 5 (100%)	1 of 5
LY3022855 - 100 mg Q2W Breast Cancer	1 of 5 (20%)	5 of 5 (100%)	1 of 5
LY3022855 - 100 mg QW Breast Cancer	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer	4 of 8 (50%)	8 of 8 (100%)	0 of 8
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32847933Autio 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.
A Study of LY3022855 In Participants With Breast or Prostate CancerLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Neoplasms

Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3022855 in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets (time frame: Baseline to Day 8 after 1st dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265536, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.