Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
NCT Number: NCT06504368
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumors, Adult
Interventions: DRUG: DCR-PDL1
Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-29
Completion Date: 2027-12-31
Locations: Next Oncology, San Antonio, Texas, 78229, United States

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.

Primary Outcome Measures: 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, Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position., 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., 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., Baseline up to week 8|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, 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., 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., 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., Baseline to week 8|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, A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems., Baseline to week 8
Secondary Outcome Measures: Pharmacokinetic Plasma Concentrations of DCR-PDL1, Pre-dose up to 48 hours post-dose|Pharmacokinetic Urine Concentrations of DCR-PDL1, Up to 8 hours post-dose