Breast Cancer Clinical Trial
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants 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.
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
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
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There are 9 Locations for this study
Los Angeles California, 90024, United States
San Francisco California, , United States
Denver Colorado, 80218, United States
Sarasota Florida, 34232, United States
Boston Massachusetts, 02215, United States
New York New York, 10065, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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