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A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Sponsor: Eli Lilly and Company
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
353
Start Date
2013-11-15
Completion Date
2023-07-22
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
gemcitabine/nab-paclitaxel
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Capecitabine
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Pazopanib
Pazopanib administered orally daily continuously
Pembrolizumab
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Paclitaxel
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
nivolumab
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Gemcitabine/carboplatin
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Locations (10)
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