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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
353
Daily subcutaneous injections of pegilodecakin up to 12 months
Day 1 of every 21 day cycle
Intravenous administration on Day 1 and 2 of every 14 day cycle
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Pazopanib will be administered orally daily continuously
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
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
Safety and tolerability as measured by incidence of adverse events
Time frame: up to 12 months
Pharmacokinetic (PK) parameters
PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).
Time frame: up to 12 months
Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)
Time frame: up to 12 months
Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)
Time frame: approximatley 4 months
Anti-Pegilodecakin antibody formation
Time frame: up to 12 months
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