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

Condition(s) studied

Investigational drug(s) / intervention(s)

DCR-PDL1: Solution for IV Infusion

Study summary

The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.

Eligibility

Primary outcome measure(s)

• Incidence and Nature of Adverse Events (AEs) — Baseline to week 8
• Incidence of Dose-limiting Toxicities (DLTs) — Baseline to week 8
• Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature — Baseline up to week 8
  Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
• Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure — Baseline up to week 8
  Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.
• Change From Baseline in Vital Signs: Pulse and Respiratory Rate — Baseline up to week 8
  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.
• Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate — Baseline to week 8
• Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals — Baseline to week 8
  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.
• Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals — Baseline to week 8
  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.
• Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula) — Baseline to week 8
  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.
• Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes — Baseline to week 8
• Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV) — Baseline to week 8
• Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH) — Baseline to week 8
• Change from Baseline in Hematology Parameter: Hemoglobin — Baseline to week 8
• Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC) — Baseline to week 8
• Change from Baseline in Coagulation Parameter: International normalized ratio (INR) — Baseline to week 8
• Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) — Baseline to week 8
• Change from Baseline in Coagulation Parameter: Fibrinogen — 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) — Baseline to week 8
• Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin — Baseline to week 8
• Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN) — Baseline to week 8
• Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Specific Gravity — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Blood — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Ketones and Nitrite — Baseline to week 8
• Change from Baseline in Urinalysis Parameter: Leukocyte esterase — Baseline to week 8
• Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems — Baseline to week 8
  A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.

Trial sites (2)

More Dicerna Pharmaceuticals, Inc., a Novo Nordisk company trials in the USA

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