An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors

Primary

• 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

  Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

  Time frame: Baseline up to week 8

• Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

  Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

  Time frame: Baseline up to week 8

• Change From Baseline in Vital Signs: Pulse and Respiratory Rate

  Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  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

  ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  Time frame: Baseline to week 8

• Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals

  ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  Time frame: Baseline to week 8

• Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)

  ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  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

  A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.

  Time frame: Baseline to week 8