A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:November 2013
End Date:February 19, 2020

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A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors

This is a first-in-human, open-label, dose escalation study to evaluate the safety and
tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily
subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.


Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to
melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell
carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung
carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is
available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

- Tumors with all histological diagnosis or tissue origin may be enrolled

- Participants must have failed prior standard curative chemotherapy for their disease,
refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin
is added represents an acceptable standard treatment for their disease.

- Measurable or evaluable disease according to irRC or bone metastatic disease
evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for
castration-resistant prostate cancer (CRPC)

- At least 18 years of age

- Performance Status of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Hematologic malignancies

- Pregnant or lactating

- Present or history of neurological disorders such as Multiple Sclerosis and Guillain
Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS)
disorders

- Myocardial infarction within the last 6 months

- Unstable angina, or unstable cardiac arrhythmia requiring medication

- Surgery within the last 28 days

- Systemic fungal, bacterial, viral, or other infection

- History of bleeding diathesis within the last 6 months

- Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
We found this trial at
10
sites
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Sarasota, FL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Patrick Ott, MD, Phd
Phone: 617-582-7603
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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mi
from
Boston, MA
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Denver, Colorado 80218
Principal Investigator: Gerald Falchook
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Denver, CO
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Naing Aung, MD
Phone: 713-563-1930
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Los Angeles, California 90095
Phone: 310-794-6892
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Jeffrey Infante, MD
Phone: 877-691-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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mi
from
Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Karen Autio, MD
Phone: 646-888-3359
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Oklahoma City, Oklahoma 73104
Phone: 405-271-8778
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mi
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Oklahoma City, OK
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San Antonio, Texas 78229
Principal Investigator: Kyrakos Papadopoulos, MD
Phone: 210-593-5265
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San Antonio, TX
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1635 Divisadero Street
San Francisco, California 94143
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mi
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San Francisco, CA
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