DCR-PDL1Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors

Arms

Interventions

Primary outcome measure

• Incidence and Nature of Adverse Events (AEs) [ Time Frame: Baseline to week 8 ]
• Incidence of Dose-limiting Toxicities (DLTs) [ Time Frame: Baseline to week 8 ]
• Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature [ Time Frame: Baseline up to week 8 ]
• Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure [ Time Frame: Baseline up to week 8 ]
• Change From Baseline in Vital Signs: Pulse and Respiratory Rate [ Time Frame: Baseline up to week 8 ]
• Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate [ Time Frame: Baseline to week 8 ]
• Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals [ Time Frame: Baseline to week 8 ]
• Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals [ Time Frame: Baseline to week 8 ]
• Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Hematology Parameter: Hemoglobin [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Coagulation Parameter: International normalized ratio (INR) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Coagulation Parameter: Fibrinogen [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Clinical Chemistry Parameter: Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH) and Creatine kinase (CK) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN) [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Specific Gravity [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Blood [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Ketones and Nitrite [ Time Frame: Baseline to week 8 ]
• Change from Baseline in Urinalysis Parameter: Leukocyte esterase [ Time Frame: Baseline to week 8 ]
• Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems [ Time Frame: Baseline to week 8 ]