A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02009449
- Run by
- Eli Lilly and Company
- People needed
- 353
- Starts
- 2013-11-15
- Expected to finish
- 2023-07-22
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA Medical Hematology & Oncology — Los Angeles, California, United States
- UCSF — San Francisco, California, United States
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Florida Cancer Specialists & Research Institute — Sarasota, Florida, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program — Oklahoma City, Oklahoma, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.