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

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

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000