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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCR-PDL1 | Experimental | Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCR-PDL1 | Drug | Solution for IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Male or female adults, aged greater than or equal to (≥) 18 years.
Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma
Measurable disease according to RECIST version 1.1.
Malignancy not currently amenable to surgical intervention.
ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology | Recruiting | Irving | Texas | 75039 | United States | |
| Next Oncology |
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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 |
| Recruiting |
| San Antonio |
| Texas |
| 78229 |
| United States |