NCT06504368 · Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
What this study is about
The study will evaluate the safety, tolerability, and how the drug moves through the body of given through a vein (IV) 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 given through a vein (IV) (IV) doses.
View original scientific description
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.
Interventions
DRUG
DCR-PDL1
Solution for IV Infusion
Primary outcome measures
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
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
Time frame: 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
Time frame: 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
Time frame: Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals
Time frame: 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
Time frame: 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)
Time frame: 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
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
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- that is refractory to standard therapy known to provide clinical benefit for their condition OR
- have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR
- have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR
- for which no standard therapy is available
- 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
- Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
- Other protocol defined exclusion criteria could apply
Where
- Irving, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2025 · Source of record for eligibility and locations