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DCR-PDL1 for Advanced Solid Tumors

This study is testing a drug called DCR-PDL1 given through an IV (intravenous, into a vein) to adults with advanced solid tumors or non-Hodgkin's lymphoma. These are cancers that have either not responded to standard treatments or have come back. The main goals are to see how safe DCR-PDL1 is, how well your body tolerates it, and how your body processes the drug. You would be part of a group receiving different doses of DCR-PDL1, starting with lower doses and gradually increasing. The study aims to enroll 32 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves 32 participants and will test increasing doses of DCR-PDL1 in different groups.
What's involved
You would receive multiple intravenous doses of DCR-PDL1 in treatment cycles. Safety and vital signs will be monitored from the start of treatment up to 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety, including adverse events (side effects) and vital signs, will be monitored from the start of treatment up to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06504368

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
~32 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:DCR-PDL1

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and Nature of Adverse Events (AEs)
Measured over Baseline to week 8
+27 more outcomes measured

Conditions

Solid Tumors, Adult

Explore related trials

Non-Hodgkin LymphomaSolid Neoplasm

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.

What this trial 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 TemperatureBaseline 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 PressureBaseline 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 RateBaseline 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 RateBaseline to week 8
  • Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervalsBaseline 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 intervalsBaseline 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, ReticulocytesBaseline 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: HemoglobinBaseline 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: FibrinogenBaseline 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 AlbuminBaseline 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 PotassiumBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and UrobilinogenBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: Specific GravityBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of UrineBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: BloodBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: Ketones and NitriteBaseline to week 8
  • Change from Baseline in Urinalysis Parameter: Leukocyte esteraseBaseline to week 8
  • Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systemsBaseline to week 8

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